Methods and devices for treating sleep apnea and snoring

ABSTRACT

Methods and devices to prevent and/or treat breathing disorders (e.g., upper airways disorders) in mammals related to impaired airflow are described. Methods and devices apply force to soft tissue that avoids obstruction of airflow in the mammel&#39;s airway. Breathing disorders that are avoided by the methods and/or devices include apnea.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 11/672,019, filed Feb. 6, 2007, which is a non provisionalapplication that claims the benefit of U.S. Provisional PatentApplication No. 60/765,638, filed on Feb. 6, 2006, these applicationsare hereby incorporated by reference herein. This application is also acontinuation-in-part of U.S. patent application Ser. No. 10,597,590,filed Jul. 31, 2006, which is a national stage filing under 35 U.S.C. §371 of International Patent Application No. PCT/US2005/006430, filedFeb. 28, 2005, which claims the benefit of U.S. Provisional PatentApplication No. 60/547,897, filed Feb. 26, 2004, all of whichapplications are hereby incorporated by reference herein.

FIELD OF THE INVENTION

This invention relates to methods and devices for maintaining upperairway patency.

BACKGROUND OF THE INVENTION

Snoring, upper airway resistance syndrome, and obstructive sleep apneasyndrome (OSAS) are all related to narrowing or obstruction of the upperairway during sleep (sleep disordered breathing). According to theNational Institutes of Health (NIH), approximately 18 million Americanshave sleep apnea (sleep disordered breathing), but fewer than 50% arepresently being diagnosed. According to the National Highway Traffic andSafety Administration (NHTSA), 100,000 accidents and 1,500 trafficfatalities per year are related to drowsy driving. More than 50% ofAmericans over age 65 have sleep difficulties, and prevalence of sleepproblems will therefore increase as the over-65 population increases.Each year, sleep disorders, sleep deprivation, and excessive daytimesleepiness add approximately $16 billion annually to the cost of healthcare in the U.S., and result in $50 billion annually in lostproductivity.

Pathophysiology of Sleep Disorders

Sleep disorders are largely caused by too much soft tissue in thethroat. Humans are unique because their upper airway has a curved shape,an anatomical change that is related to the evolution of human speech.As a result the upper airway of humans is more flexible than that ofother species and is more prone to collapse under negative pressure. Inthe awake state a certain amount of tone is present in upper airwaymuscles to prevent this collapse. However, during sleep muscle tonedecreases in upper airway muscles and in certain susceptible individualsthis relaxation allows the airway to collapse (Horner R L. Motor controlof the pharyngeal musculature and implications for the pathogenesis ofobstructive sleep apnea. Sleep 1996; 19: 827-853).

The upper airway refers to the air filled spaces between the nose andthe larynx (FIG. 1). The most relevant part of the upper airway forsleep disorders is the air cavity at the back of the throat called thepharynx. The pharynx can be divided into three anatomical levels (FIG.2):

1) The nasopharynx is the part of the pharynx in the back of the nasalcavity.

2) The part at the back of the mouth is called the oropharynx. Theoropharynx is the space between the tongue and the pharynx from the edgeof the soft palate to the tip of the epiglottis. To be more precise itis best called the velopharynx. This level corresponds to that part ofthe pharynx containing the velum (soft palate) and tongue curve.

3) The hypopharynyx is behind the tongue base.

The velopharynx is more susceptible to collapse because there are moresoft tissue structures, leaving less room for airflow. The majorstructures of the velopharynx are the soft palate and the tongue, bothof which are very flexible. The soft palate acts as a barrier betweenthe mouth and the nose. In many people it is longer than necessary andextends down between the tongue and pharyngeal wall. The tongue is thelargest muscular organ of the upper airway and is anatomically divisibleinto a blade, body and base (FIG. 3). Most of the tongue's curve is atthe junction of the tongue body and base.

In the awake condition the structures of the velopharynx maintain theirshape because of continuous tone of their internal muscles. When thistone decreases, such as during sleep, these structures become quiteflexible and distensible. Without the normal muscle tone that keeps themis place, they tend to collapse at relatively low negative pressures.Although muscles relax throughout the body during sleep many of therespiratory muscle remain active. Specifically, the major muscle thatpulls the tongue forward, the genioglossus muscle, has been reported toshow normal or increased activity during obstructive apneas. Normallythe genioglossus is capable of moving the tongue forward and evenprojecting it out of the mouth. Why the genioglossus muscle sometimesfails to prevent obstructions has not been explained.

During inspiration the chest wall expands and causes negative pressureto draw air into the nose and mouth and past the pharynx into the lungs.This negative pressure causes upper airway soft tissue to deform,further narrowing the airway. If the airway narrows enough the air flowbecomes turbulent causing the soft palate to vibrate. The vibration ofthe soft palate produces the sound known as snoring. Snoring isextremely common effecting up to 50% of men and 25% of women. By itselfsnoring is not a medical problem although it can be a tremendous problemfor the patient's bed partner and a major cause of marital strain.

A small amount of decreased airflow or brief obstructions occur in allhumans during sleep. These episodes are counted as medically significantif airflow is decreased more than 50% of normal for more then 10 seconds(hypopnea) or if airflow is obstructed for more then 10 seconds (apnea).The number of apneas and hypopneas that occur during each hour of sleepis measured to diagnose the severity of the sleep disorder. Theseepisodes of hypopnea or apnea often cause some degree of arousal duringsleep. Although the patient does not awaken to full consciousness, thesleep pattern is disturbed causing the patient to feel sleepy during theday. If the frequency of hypopnea or apnea is less than 5 episodes anhour it is called upper airway resistance syndrome. These patients oftenshow symptoms related to the sleep disruption. Specifically, thesepatients are excessively sleepy during the day. In addition more subtlesymptoms such as depression and difficulty in concentrating are alsocommonly reported. Snoring, hypopnea, and apnea can all be characterizedas breathing disorders.

Technically the diagnosis of OSAS is defined as an average of more than5 episodes of hypopnea or apnea during each hour of sleep. Although theairway is obstructed the patient makes repeated and progressively moreforceful attempts at inspiration. These episodes are silent andcharacterized by movements of the abdomen and chest wall as the patientstrains to bring air into the lungs. Episodes of apnea can last a minuteor more, and during this time the oxygen levels in the blood decrease.Finally, either the obstruction is overcome, usually producing a loudsnore, or the patient awakes with the feeling of choking.

Very common symptoms in OSAS patients are morning headaches and acidreflux. During airway obstructions the forceful attempts to inspire aircan cause tremendous negative pressure in the chest. These high negativecan draw acid up the esophagus from the stomach. The acid can travel allthe way into the mouth and cause inflammation of the vocal cords andnasal mucosa. The presence of the acid in the upper airway causes reflexbronchoconstriction in the lung that is similar to an asthma attack. Ifeven a small amount of acid enters the lung it can cause the vocal foldsto close tightly and itself cause a prolonged apnea called laryngospasm.In many patients the repeated stretching of the espophageal sphinctercauses chronic changes and these patients can have acid reflux duringthe day.

Most importantly, sleep disorders can cause serious medical disordersand death. Apneas cause a large strain on the heart and lungs. Over timethe many repeated episodes of apnea cause chronic changes leading tohypertension. Long periods of apnea allow the oxygen levels in the bloodto decrease. In turn the low oxygen can cause heart attacks or strokes.

Treatment of Sleep Disorders

Although OSAS occurs in both children and adults the cause and treatmentis very different. OSAS in children almost always occurs when the childhas large tonsils, and tonsillectomy cures the condition. Tonsilsnaturally decrease in size with age and are rarely a problem in adults.Instead susceptible adults usually have enlargement of their tongues,soft palate and/or pharyngeal walls. This enlargement is mostly due tofat deposits within these structures.

Adult sleep disorders are difficult to treat for a variety of reasons.The upper airway is a very mobile structure that performs the criticalfunctions of swallowing and speech. These functions are easilycompromised by surgical procedures or other interventions. In addition,the upper airway also has a large amount of sensory innervation thatcauses reflex gagging and coughing. Theoretically a physical stent thatis placed in the oral cavity and pharynx would be completely effectivein relieving sleep apnea. When a patient is totally unconscious, such aswhen they are anesthetized for surgery, the airway can be stented openby placing a curved oral tube into the mouth and pharynx. In addition,endotracheal tubes establish a secure airway for artificial ventilation.However, after anesthesia wears off, patients immediately sense andreact to the foreign objects in their throats and expel them. Thereforedevices such as oral and endotracheal tubes, or anything similar, cannotbe used for the treatment of OSAS.

Although physical stents cannot be used for OSAS an indirect way ofstenting the upper airway with positive air pressure is the most commonprescribed treatment for OSAS. This method is called continuous positiveairway pressure (CPAP). CPAP requires the use of a mask tightly attachedaround the nose and connected to a respirator. The exact amount ofpositive pressure is different for each patient and must be set byovernight testing using multiple pressures. The positive pressure actslike a stent to keep the airway open. CPAP is not a cure but a therapythat must be used every night. Although many OSAS patients are helped byCPAP it is not comfortable for the patient or their bed partner.Patients often cannot tolerate the claustrophobic feeling of a masktightly attached to their face. In addition they are often manytechnical problems with maintaining a proper seal of the mask to theface. For these reasons up to half of all patients who are prescribedCPAP stop using it within 6 months (Sanders, “Medical Therapy for SleepApnea,” Principles and Practice of Sleep Medicine, 2nd Edition, pp.678-684)

Tracheotomy

The only completely effective surgical therapy for OSAS is to bypass theentire upper airway by performing a permanent tracheotomy, a surgicalprocedure that forms a direct connection to the trachea through theneck. This is a dangerous procedure reserved for the worst cases whenthere is a high risk of serious medical complications from OSAS.Notably, temporary tracheotomies are often performed on patients withsevere OSAS to control the airway before performing before any otherprocedure is performed on their upper airway. The reason is that thesepatients are at high risk of acute airway obstruction and death if thereis any swelling in their airways. Due to the tremendous excess ofswollen tissue in their upper airways OSAS patients are very difficultto intubate under emergency conditions. Similarly there is tremendousamount of fat in the neck that makes emergency tracheotomies extremelyhazardous.

Prior to current conservative measures, post operative deaths were notuncommon in severe OSAS patients. Moreover these patients often haveacclimated to breathing against resistance, and when the resistance issuddenly removed their respiratory drive decreases. Even today thestandard of care in treating most OSAS patients is to have them underclose observation in an intensive care unit or recovery room aftersurgical procedures.

Soft Palate Procedures for Snoring

As the soft palate vibrates more than other tissues it plays adisproportional role in snoring. Various surgical therapies areavailable that shrink or stiffen the soft palate. The main procedureused is called uvulopalatopharyngoplasty (UPPP). UPPP excises excesssoft tissue of the pharyngeal walls and soft palate with a surgicalscalpel. Because so much mucosa of the pharyngeal area is traumatizedduring a UPPP there is a large amount of post operative swelling andsevere pain. In selected patients who snore but have no obstructionsmore limited versions of the UPPP can be done with lasers or electricalcautery.

Newer procedures minimize trauma to the mucosa and use needles to reachthe underlying soft tissue to shrink its volume or stiffen it so that itresists vibration. Electrodes can be inserted into the soft palate todeliver radiofrequency energy that shrinks or stiffens the palate(Powell, NB, et al (1998) Radiofrequency volumetric tissue reduction ofthe palate in subjects with sleep-disordered breathing. Chest 113,1163-1174.) (Somnoplasty; Somnus; Mountainview, Calif.). Mild causticagents can be injected that decrease the volume of the soft palate. U.S.Pat. No. 6,439,238 to Benzel teaches the application of a stiffeningagent to the surface of the soft palate. Most recently, office basedimplantation of plastic inserts to stiffen the soft palate has beenapproved by the FDA (Pillar® Procedure, U.S. Pat. No. 6,546,936: Methodand apparatus to treat conditions of the naso-pharyngeal area).

The fundamental shortcoming of all procedures that target the softpalate, including the newer techniques, is that they only partiallyimprove OSAS (Loube DI (1999) Technologic Advances in the Treatment ofObstructive Sleep Apnea Syndrome. Chest. 1999; 116:1426-1433, Doghramji,K, et al (1995) Predictors of outcome for uvulopalatopharyngoplasty.Laryngoscope 105, 311-314). Although studies report a decrease in thenumber of apneas, these patients are rarely cured. Evidently thecritical structure causing OSAS is not the soft palate but the tongue.

Tongue Base Procedures For OSAS

The methods used to treat the tongue base in OSAS are either topermanently decrease its volume, to decrease its flexibility or to movethe entire tongue forward. Surgical excision of the tongue base has beenpoorly effective. The results for scalpel or laser resection of thetongue base in OSAS treatment have not been good enough to recommendcontinued application of these procedures (Mickelson, S A, Rosenthal, L(1997). Midline glossectomy and epiglottidectomy for obstructive sleepapnea syndrome. Laryngoscope 107, 614-619).

More recently radiofrequency (U.S. Pat. No. 5,843,021 to Edwards) andultrasonic (U.S. Pat. No. 6,409,720) energy have been proposed to shrinkand stiffen the tongue base with radiofrequency energy. Theradiofrequency energy is delivered via needle electrodes that areinserted into the tongue base to cause a lesion that scars and shrinksover time. To avoid postoperative swelling and pain a limited amount oflesioning is done in a single session and patients require an average of5 treatments. About a third of patients have greater than 50%improvement in their OSAS. However, approximately a fourth of patientshave significant post operative complications, including, tongue baseulceration and abscesses, and temporary tracheotomy.

A recent introduced device for tongue base advancement is the Repose®system (Influent Corp; San Francisco, Calif.). The procedure isperformed under general anesthesia, and the Repose® system includesinsertion of a screw at the base of the mandible. The screw containsattachments for a permanent suture that is tunneled under the mucosa ofthe floor of the mouth to the back of the tongue, then passed across thewidth of the tongue base, and brought back to attach to a metal hookscrewed into the bone of the mandible. The suture is tightened todisplace the tongue base forward, and caution must be observed toprevent excess tension leading to necrosis of tissue. Unfortunatelystudies of the Repose® procedure show that it is ineffective ateliminating OSAS. Only 1 of 15 patients was cured of OSAS while 2patients had to have the suture removed due to pain and swelling.

More aggressive surgical procedures require reconstruction of themandible, facial, skeleton or the hyoid bone. An example of the art isU.S. Pat. No. 6,161,541 to Woodson that teaches a method of surgicallyexpanding the pharyngeal airway. These procedures require extensivesurgery with higher risks and much longer recovery periods.

Other proposed methods for treating the tongue base include stiffeningthe soft tissue by injection of sclerosing particles U.S. Pat. No.6,742,524 or other implanted material US Patent Application PublicationNo. 20050004417A1.

Neuroprosthetic Devices

Various neuroprosthetic devices have been invented that stimulate upperairway muscles. U.S. Pat. No. 4,907,602 to Sanders describestransmucosal stimulation to dilate the airway; U.S. Pat. No. 5,792,067to Karell teaches an intraoral device that applies electricalstimulation to the hard palate, soft palate or pharyngeal area to inducecontraction of the upper airway muscles; U.S. Pat. No. 5,190,053 to Meerteaches an intraoral device that applies electrical stimulation to thegenioglossus muscle via electrodes located on the mucosa on the floor ofthe mouth on either side of the frenulum. In addition U.S. Pat. No.5,591,216 to Testerman describes a totally implantable device tostimulate the nerves to the genioglossus muscles. In addition, WIPOPatent Application No. 04064729 to Gordon describes a neuroprostheticdevice that can be injected into the soft palate to treat snoring. Atpresent these devices have not been clinically proven. In summary, sleepdisorders are a significant health problem without an acceptablesolution and there is a need in the art for new and more effectivetherapies.

SUMMARY OF THE INVENTION

While not wishing to be bound by any single theory my studies of humantongue anatomy suggest that episodes of obstruction evolve by a sequenceof events (FIGS. 4A-4F). The initial inciting event is the deformationof a relatively small part of the tongue 451. Under certain conditionsdeformation begins in soft tissue on the top of the tongue 451,particularly in the area of the tongue curve, and specifically near thecenter line of the tongue curve. As this tissue deforms it narrows theairway and causes more negative pressure thereby causing greaterdeformation. This feedback cycle in turn deforms enough tissue in thearea to cause a complete obstruction in the velopharyngeal area.

If an initial obstruction occurs near the end of inspiration, theobstruction is relieved by an expiration, or by action of thegenioglossus muscle. However, if the obstruction occurs at the beginningof inspiration reflexes trigger stronger inspiratory effort that furtherlowers airway pressure. This increased negative pressure causesdeformation and collapse of most of the tongue base 453. At this pointthe airway is firmly plugged by soft issue and activity of thegenioglossus only stretches the tongue tissue that is plugged and cannotdislodge it.

Therefore the tongue curve is the critical area that initiates thecascade leading to obstruction. This relaxed muscle is very flexible andeasy to deform, however, the converse is also true, very little force isneeded to prevent this deformation. Therefore if sufficient counterforceis exerted at the proper localized area of the tongue 451 it can preventobstruction without noticeable effects on speech and swallowingmovements.

How a device could prevent the deformation and collapse of the tonguecurve is not a trivial problem:

-   -   This area of the tongue is very mobile during speech and        swallowing, therefore the amount of force exerted must be low        and highly localized. It is unacceptable to render the area        immobile, as would be done if were stiffened by a large implant        or scar tissue.    -   The whole area of the velopharynx has extensive sensory        innervation, and relatively minor stimulation there causes        either a gag or a swallow.    -   The tongue base and body have a larger blood supply than        comparable muscles elsewhere in the body. Any implant placed in        the area has a high probability of causing internal bleeding        with potentially catastrophic tongue swelling.    -   Soft tissue and tongue in particular remodel easily.        Specifically sutures or implants that exert force cause the        tissue to remodel to relieve that force. This is known as the        “cheese cutter” effect. Therefore, the forces applied to the        soft tissue and/or tongue must be relatively low and applied for        limited periods.    -   Humans upper airway anatomy is highly variable, and the        pathological anatomy of sleep apnea patients is even more        variable. Moreover the upper airway anatomy of sleep apnea        patients changes over time as the disease progresses or        improves.    -   Finally, OSAS patients have borderline airways that can obstruct        after even minor amounts of swelling such as that following        surgical manipulation. Therefore it not obvious how a device        could both exert force in the area yet avoid swelling.

Moreover to be maximally effective and to get patient and physicianacceptance the device would ideally require additional qualities:

-   -   It should be capable of being inserted as an outpatient        procedure.    -   Preferably the device could be removed during the day and        reinserted by the patient at night.    -   It would be adjustable to conform to the specific needs of the        patient.    -   It would be comfortable for the patient.    -   When the device was in place it would not be noticeable to        anyone else.

There is a tremendous variability in human upper airway anatomy, andeven further variation in the pathological changes contributing to sleepapnea and related disorders. Moreover, the pathological anatomy changesover time in each patient as their condition improves or deteriorates.No single method and device is able to treat all contingencies.Therefore there is a critical need for methods and devices that areoptimized for different sites in the upper airway.

Embodiments of the invention include methods and devices to prevent ortreat upper airway breathing disorders related to impaired airflow inmammals. These breathing disorders are, without limitation, snoring,upper airway resistance syndrome, and obstructive sleep apnea. Inaddition, this invention is applicable to airway disorders in animalsincluding but not limited to dorsal displacement of the soft palate inhorses and brachycephlic obstructive airway syndrome in certain breedsof dog. Those skilled in the art will readily appreciate thatapplication of this invention can be applied to other conditions of theupper airway.

One aspect of the invention prevents airway obstruction by dilating theairway or preventing the tissue from deforming. It enlarges the airwaywhen excess tissue is present and also counteracts the deforminginfluence of negative airway pressure on the relaxed soft tissue ofupper airway structures. These structures include, without limitation,the tongue, soft palate, pharyngeal walls and supraglottic larynx.

FIGS. 5A-5D, depict one embodiment of a device referred to as a tissueretractor or as a Linguaflex tongue retractor (LTR) (notwithstandingthat the use of the device as disclosed herein the tissue retractor orLTR device is not limited to use in the tongue or to use for tissue ortongue retraction). The LTR includes a retractor member (R), a shaft(S), and an anchor member (A). In some embodiments a retractor member(R) is physically coupled to the soft tissue of the tongue base. Theshaft (S) passes through the midline of the tongue to connect with ananchor member (A). The anchor member (A) imparts counterforce throughthe shaft (S) to the retractor member (R), thereby preventingdeformation of the soft tissue.

One aspect of this invention describes improvements to the retractormember, shaft and anchor member that increase the efficacy of the devicewhile decreasing patient discomfort. Improvements of the tissueretraction (e.g., the LTR) components include but are not limited to aretractor member with a retractor head that collapses to fit within anarrow delivery device and expands after insertion; a shaft thatpassively adjusts its length and tension in response to surroundingtongue activity; and a modified anchor that is adjustable by the patientand attaches to a bolster (e.g., a soft bolster), a partially implantedreceptacle in the mouth, and/or a dental appliance.

One aspect of the invention is a method of making the implant morecomfortable by allowing the device to be under little or no tensionduring the day, in the “unloaded” state, and to increase the tension totherapeutic levels at night, in the “loaded” state. This loading andunloading method increases the comfort for the patient and allows thepatient a large degree of control. The method and the devices thatimplement the method are of great importance, because the lack ofpatient compliance is perhaps the largest problem with current sleepapnea therapies. A method and/or device that is comfortable to thepatient has an increased likelihood of patient compliance.

Another aspect of this invention is that additional sites in and aroundthe tongue can unexpectedly be treated to prevent airway disorders.Non-limiting examples of these sites are the base of tongue, the mucosacovering the tongue, the tongue frenulum, the pharyngoglossal fold, thepalatoglossal fold, the aryepiglottic fold, the lateral pharyngeal wall,and the soft palate. An improved tissue retractor (e.g., an LTR) appliedto one or more of these sites directly or indirectly stiffens anddisplaces tissue and/or mucosa in, for example, the tongue base, thesoft palate, and the lateral pharyngeal wall, and enlarges thevelopharynx thereby avoiding obstruction of the patient's airway. Eachsite has specific anatomy and suitable tissue retractors are disclosedfor use in various anatomical areas to perform efficiently and withminimal risk and discomfort to the patient.

One aspect of this invention is a tissue retractor (e.g., an LTR) thatindirectly retracts tongue base via its implant site in the frenulumarea. Placement in the frenulum area simplifies the insertion,adjustment, and maintenance of the device. Another aspect of thisinvention describes a highly localized and fully implantable tissueretractor (e.g., LTR) that is inserted into the base of tongue tostiffen lax surface mucosa or mechanically couple it to internal tonguestructures.

Another aspect of this invention is a tissue retractor (e.g., an LTR)inserted in or around the pharyngoglossal fold. This site allowsretraction and stiffening of tongue base tissue as well as the softpalate and lateral pharyngeal wall. The advantage of the pharyngoglossalfold site is its minimal invasiveness, safety and its beneficial effecton multiple different structures.

Another aspect of this invention is a method and device to remodel upperairway tissue in order to enlarge the pharyngeal airspace. Tissuesremodeled include but are not limited to tongue base, palatine tonsil,pharyngeal wall, and soft palate. Preferably these tissues are eithercompressed to decrease their volume, displaced to provide space in otherareas, or reshaped. In some embodiments, the tissue remodel effect lastsfrom months to years after the device(s) have been removed. To achievethis persistent beneficial effect, devices would preferably exert forceon the tissue for a time that ranges from about 1 week to about 1 yearor from about 1 month to about 6 months.

Another aspect of this invention includes non-invasive methods anddevices that reversibly couple to mucosa to grasp, move and/orreposition soft tissue. Suitable non-invasive methods use magnets,adhesives, vacuum, and/or mechanical leverage. In one embodiment acurved retractor member is reversibly inserted into one or more selectedsites. In another embodiment indwelling clamps are placed on one or moreof the PGF, tonsillar folds, the soft palate and other soft tissuefolds. A suitable retractor member can be loaded as needed by couplingthe retractor member to a modified anchor inside or outside of thepatient's mouth. In still another embodiment, the floor of mouth isprotracted to displace the tongue base. In a still further embodiment avacuum reshapes the tongue to decrease the volume of the tongue in thetongue base. Another aspect of this invention describes tissueretractors (e.g., LTR's) specifically adapted to prevent dorsaldisplacement of the soft palate in horses.

The tissue retractor (e.g., the LTR) can pass through tissue and haveits retractor member and anchor member ends outside of tissue, have onlyone end outside of tissue and exposed, or the entire device can beimplanted. The shaft of the device can pass deeply into tissue, or passsuperficially just beneath the mucosa. The retractor member and theanchor member are preferably shaped to fit in a site so as to distributeforce evenly. For example, all or a portion of the tissue retractor hasa flat shape for placement in flat or mildy curved surfaces such as themid tongue base, pharyngeal wall, and soft palate. All or a portion ofthe tissue retractor is wedge shaped for placement at or near the depthsof the pharyngoglossal fold and lateral margin of the soft palate. Allor a portion of the tissue retractor (e.g., the anchor member) is Vshaped for placement at or near the frenulum. All or a portion of theanchor member is T shaped for placement at, near, or through the teeth.The materials used to form the tissue retractor, the implant, theretractor member and/or the anchor member can include any non-reactivebiocompatible materials. Suitable non-reactive biocompatible materialsare known in the art. Non-limiting examples of suitable rigid materialsinclude stainless steel, titanium, ceramics, and plastics. Non-limitingexamples of suitable elastomeric materials include silicon and rubber.

In some embodiments, the force needed to displace the tongue anteriorlyor the soft palate superiorly varies from about 0.001 gram to about10,000 grams, about 0.1 gram to about 1000 grams, or about 10 to about100 grams. This force could be applied over a time that ranges fromabout 0.01 seconds to permanently, about one minute to about 1 month,for the duration of sleep, or during episodes of restricted upper airwayflow.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be more readily understood from the detaileddescription of exemplary embodiments presented below considered inconjunction with the attached drawings, of which:

FIG. 1 is a drawing of the human upper airway in the mid sagittal plane;

FIG. 2 is a simplified schematic drawing of the areas of the pharynx,the tongue, and surrounding structures;

FIG. 3 illustrates Anatomical landmarks of the tongue;

FIGS. 4A-4F illustrate a Mechanism of airway obstruction and the effectof certain therapies;

FIGS. 5A-5D illustrate an Embodiment of an LTR device;

FIGS. 6A-6E illustrate a Retractor member;

FIGS. 7A-7C illustrate a Shaft member;

FIGS. 8A-8H illustrate an Anchor member, bolster;

FIGS. 9A-9E illustrate an Anchor member, dental;

FIGS. 10A-10C illustrate an Anchor member, frenulum area;

FIGS. 11A-11E illustrate a Frenulum area embodiment;

FIGS. 12A-12F illustrate a Tongue base implant;

FIGS. 13A-13L illustrate Tongue base embodiments;

FIGS. 14A-14E illustrate The Superior Pharyngoglossal Fold;

FIGS. 15A-15F illustrate Pharyngoglossal Fold embodiments;

FIGS. 16A-16F illustrate Pharyngoglossal Fold embodiments;

FIGS. 17A-17C illustrate Soft Palate embodiments;

FIGS. 18A-18F illustrate Tonsillar Fold embodiments;

FIGS. 19A-19F illustrate Soft palate embodiments;

FIGS. 20A-20F illustrate Veterinarian embodiments;

FIGS. 21A-21H illustrate a Non-invasive PGF retractor;

FIGS. 22A-22H illustrate a Non-invasive retraction, clamp embodiment;and

FIGS. 23A-23N illustrate Non-invasive protraction and vacuum devices.

It is to be understood that the attached drawings are for purposes ofillustrating the concepts of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1. Drawing of the human upper airway in the mid sagittal plane.

FIG. 2. Simplified schematic drawing of the areas of the pharynx, thetongue and surrounding structures

-   -   NP, Nasopharynx    -   VP, Velopharynx    -   HP, Hypopharynx    -   SP, Soft palate    -   P, Hard palate    -   T, Tongue    -   GG, Genioglossus muscle

FIG. 3. Anatomical landmarks of the tongue. The tongue will be definedas the grey area of this schematic. From front to back the tongue isdivided into a blade, body, and base. The genioglossus muscle (GG)inserts into a connective tissue boundary on the undersurface of thetongue (Bo). The entire region of the genioglossus muscle and its mucosais referred to as the “frenulum area”.

-   -   BA) Tongue base    -   BD) Tongue body    -   BL) Tongue blade    -   Bo) Boundary between tongue and genioglossus    -   C) Tongue curve    -   F) Frenulum    -   GG) Genioglossus muscle

FIG. 4. Mechanism of airway obstruction and the effect of currenttherapies.

4A. Shows the normal tone in a tongue 451 while a patient is awake. Thetongue 451 remains in position allowing the airway to remain open. Thearrow 469 shows airflow through the airway, the small arrow 412 showsthe relationship of pharyngeal wall 465 to the mandible 468.

4B. During sleep muscle tone is lost in the tongue 451 and the tongue451 becomes flaccid. Negative pressure in the pharynx during inspirationcauses backward collapse of the tongue 451 in the velopharyngeal area,because the airway is narrowest at that point and the tongue curve(circle) is most deformable.

4C. After the airway obstructs airflow 469 at the velopharyngeal areainspiration lowers the pressure in the pharynx further causing the base453 of tongue 451 to deform and firmly block the airway.

4D. CPAP works by pumping air 416 at high pressure through the patient'snose, thereby splinting the pharynx open.

4E. Dental devices work by moving the entire jaw forward. Depicted isthe impact of the dental device on the patient's mouth, but not thedental device itself. As the tongue 451 is attached to the soft tissuesalong the floor of the mouth, and they attach to the jaw, the tongue 451is indirectly moved to expand the airway. Note that the jaw has moved inrelation to the pharyngeal wall 465.

4F. The tissue retractor 401 (e.g., an LTR) prevents posteriordeformation of tongue 451 curve by directly restraining the tongue 451curve from moving backwards.

FIG. 5. Embodiment of the tissue retractor (e.g., an LTR) device. Shownis one embodiment of the LTR.

5A. The LTR has three main components: a retractor member (R), a shaft(S), and an anchor member (A).

5B. Side view of the tissue retractor (e.g., an LTR) inserted in atongue.

5C. Back view of tongue curve showing retractor position.

5D. Back view of tongue base showing the curved midline shape taken fromthe posterior aspect of the tongue.

FIG. 6A-6E. Retractor member. This figure illustrates a retractorcomponent of a tissue retractor 601 (e.g., an LTR) that can be mountedon a needle 635 for implantation within upper airway tissue 650 anddeploys when the needle 635 is withdrawn. The retractor member 620 isshown as an integral component of the shaft 610 and is molded as onepiece from soft elastomeric material.

6A. Four views, two side views and two front views of the retractormember 620 head. The plane of the retractor member 620 head rests atabout 150 relative to the shaft 610.

6B. Side view of retractor member 620 head mounted within a needle 635.A part of the retractor member 620 head lays on the outer surface of theneedle 635.

6C. Side view of needle 635 passing through tissue 650. Note that theretractor member 620 head lays flat against the needle 635 barrel anddoes not interfere with passage of the needle 635 through tissue 650.

6D. After the needle 635 penetrates mucosa enough to clear the tissue650 the retractor member 620 head again extends away from the shaft 610such that the retractor member 620 head rests at about 15° relative tothe shaft 610.

6E. Slight traction on the shaft 610 causes the retractor head 620 tocatch the mucosa and/or tissue 650 and come to rest in its workingposition.

FIG. 7. Shaft member 710. Shown is an improvement to the shaft of atissue retractor 701 (e.g., an LTR) that maintains its retractor tensionwhen the tongue 751 is relaxed, such as during sleep. However, duringspeech and swallowing, when the tongue base often moves backward, theactivity of the tongue 751 squeezes the shaft 710 and thereby lengthensit. In this way there is little or no resistance to the normal tongue751 movements.

7A. Schematic view of LTR in the tongue 751 with normal muscle tone.Note that the retractor member 720 head lays on the mucosal surface ofthe tongue base without indenting it.

7B. During sleep the tongue 751 loses all tone and tends to flopbackward into the airway. The retractor member 720 head then resiststhis deformation.

7C. During swallowing and speech the tongue base sometimes movesbackward. During these movements there is a strong contraction of thetongue muscles. This contraction squeezes the upper shaft 711, this inturn causes the shaft 710 to lengthen and move the tissue retractor 701.

FIG. 8. Anchor member 830, bolster 840

8A. Front view 842 of bolster 840.

8B. Top view 844 of bolster 840.

8C. Side view 846 of bolster 840.

8D. Side view of tongue 851 with unloaded tissue retractor 801 (e.g.,LTR).

8E. The anchor member 830 and the shaft 810 are pulled forward and aportion of the shaft 810 is slotted into the cleft 848 on underside ofthe bolster 840.

8F. Bolster 840 in position under tongue 851.

8G. Close up view of tissue retractor (e.g., LTR) anchor member 830sitting in the recess (i.e., the cleft 848) of the bolster 842.

8H. Top view of tongue 851 with a tissue retractor 801 (e.g., LTR)retractor member 820 and a bolster.

FIG. 9. Anchor member, dental

9A. Shows a modified anchor that is reversibly attached to the upper orlower front teeth. The anchor member 930 (A) interfaces with the teeth,the shaft 910 (S) connects to retractor/coupler 920 (R/C). Theretractor/coupler either has a retractor member 920 that interfaces withtissue, or a coupler component that connects to an implanted retractor,shaft, or anchor member of an implanted tissue retractor (e.g., an LTR).

9AA. Shows a side view of the anchor member 930 (A) the anchor member930 has depth that is wide, the shaft 910 and the retractor member 920are also depicted.

9B. Drawing of top view of tongue 951 and mandible 968 with a tissueretractor 901 (e.g., an LTR) implanted from the tongue base 953 to thefrenulum. The anchor 930 of the LTR can be reversibly attached to theR/C component 920 of the dental anchor.

9C. Another embodiment of a tissue retractor 901 having a modifiedanchor member 930 for use on the lateral teeth 998.

9D. Top view of tongue 951 and mandible 968 with a lateral dental anchormember 930. The anchor member 930 attaches to the molar tooth 998, theshaft 910 passes through or over the pharyngoglossal fold 967, and theretractor rests 920 against the posterior surface of the fold.

9E. A palatal prosthesis 972 provides an anchor member 930 with somepossible coupling extensions for retraction or protraction ofsurrounding structures including the soft palate 966, the PGF 967, thefloor of mouth 976, and the tongue 951 surface (couples at the tonguesurface at, for example, a tongue stud.

FIG. 10. Anchor member, frenulum area.

Within the genioglossus muscle 1063 are small tendons upon which musclefibers insert at various angles. The main tendon is in the middle of themuscle and smaller tendons branch off at various points. Preferably ananchor 1031 is inserted in the frenulum area 1060 such that theimplanted portion of the anchor 1031 passes through a tendon. However,the anchor 1031 can be inserted into any spot in the frenulum area 1060or inserted into soft tissue attached to the mandible 1068. The anchor1031 could be coupled to a tissue retractor (e.g., an LTR) by a varietyof mechanisms as described herein.

10A. Photograph of the side view of the tongue 1051 and mandible 1068cut in the centerline (mid-sagittal plane).

10B. Drawing of the photograph of the side view of the tongue 1051depicted in FIG. 10A.

10C. Close up of the frenulum area 1060 an anchor 1031 is inserted intothe frenulum 1060.

FIG. 11. Frenulum area embodiment.

11A. Photograph of the side view of the tongue 1151 and mandible 1168cut at the centerline. The frenulum 1160 is the front edge of thegenioglossus muscle 1163, frenulum area 1160 refers to the entiregenioglossus 1163 and surrounding mucosa. The front and rear boundariesof the genioglossus muscle 1163 are marked by solid lines. Thegenioglossus muscle 1163 attaches to a small area on the inner surfaceof the mandible 1168 and tendinous extensions from that area. It fansout from these attachments to insert mostly into connective tissue alongthe length of the body and base of the tongue 1151 called the boundarylayer 1161.

11B. Drawing of the photograph of the side view of the tongue 1151depicted in FIG. 11A.

11C. Shown is a tissue retractor 1101 (i.e., an LTR) passing through thefrenulum area 1160 and anchored externally to a dental anchor. Thedental anchor can be, for example, a tooth (located in the region of themandible 1168) over which the tissue retractor 1101 is looped. Theimplanted part of the LTR 1101 exerts anterior forces on thegenioglossus 1163 muscle fascicles 1164 and this is conveyed to theboundary layer 1161 and finally to the tongue 1151 base (arrow/1153).The arrow 1153 shows the direction of force and the displacement fromthe tongue base to the boundary by the retractor pulling the frenulumarea 1160 anteriorly.

11D. Shown is an LTR 1101 passing through the boundary layer 1161 andanchored to a modified anchor 1131 (e.g., a frenulum anchor).Displacement of the tongue 1151 is marked by the arrow.

11E. Shown is a fully implanted LTR 1101 in the frenulum area 1160connecting the boundary area 1161 in two places. Note that thebeneficial retraction of the tongue base 1153 causes some retraction ofthe tongue blade 1152, however, this retraction of the tongue blade 1152does not interfere with tongue 1151 function.

FIG. 12. Tongue base implant.

12A. Photograph of a frontal section of tongue 1251 base.

12B. Drawing of 12A. Light lines are the connective tissue of the tonguesuperior layer (SL) 1258 and the midline septum (MS) 1255. The middlelayer (ML) 1254 is the volume of the tongue 1251 beneath the (SL) 1258.

12C. Position of tissue retractor 1201 (e.g, an LTR) implant connectingSL 1258 and ML 1254.

12D. Photograph of the tongue 1251 seen in mid-sagittal plane. Ovalmarks the area of mechanical decoupling.

12E. Schematic drawing of the portion of the tongue 1251 in the boxmarked in the photograph shown in FIG. 12D.

12F. Position of tissue retractor 1201 implant.

FIG. 13. Tongue base embodiments

13A. Lateral (left) and top (right) drawings of the tongue 1351 with atissue retractor 1301 (e.g., an LTR) in which a retractor member 1320and an anchor member 1330 are connected by a shaft 1310 passingunderneath the tongue base mucosa. Shown are an anchor member 1330, aretractor member 1320, and a shaft 1310 that connects the anchor member1330 and the retractor member 1320. The shaft 1310 is shown as a dottedline when implanted in the soft tissue 1350, e.g., the tongue 1351. Theshaft 1310 is shown as a solid line when it is outside soft tissue 1350(see, FIG. 13D, for example). The arrow 1313 shows the direction ofretraction when the retractor member 1320, the shaft 1310, and theanchor member 1330 interact to exert a pressure on at least a portion ofthe soft tissue 1350.

13B. Lateral (left) and top (right) drawings of the tongue 1351 with atissue retractor 1301 (e.g., an LTR) with the shaft 1310 taking a moredirect route through the tongue 1351 between a retractor member 1320 andan anchor member 1330.

13C. Lateral (left) and top (right) drawings of the tongue 1351 with atissue retractor 1301 (e.g., an LTR) with the shaft 1310 exiting frommucosa close to the retractor member 1320 and connected to the anchormember 1330. Portions of the shaft 1310 closes to the retractor member1320 and the anchor member 1330 are beneath the mucosa and otherportions of the shaft 1310 are exterior to the tongue 1351.

13D. Lateral (left) and top (right) drawings of the tongue 1351 with atissue retractor 1301 having an implanted anchor member 1330, animplanted retractor member 1320 and a reversible attachable shaft 1310.

13E. A lateral view of a partially implantable retractor member 1320,which has a first portion 1321 implanted in soft tissue 1350 and asecond portion 1322 external to the soft tissue 1350. An anchor member1330 could likewise be partially implantable.

13F. A top view of a partially implantable retractor member 1320.

13G. A lateral view of a partially implantable retractor member 1320showing the shaft 1310 connecting to the second portion 1322 of theretractor member 1320, and the second portion 1322 is exterior to thesoft tissue 1350.

13H. A lateral view of a partially implantable retractor member 1320with the second portion 1322 extension depressed such that the secondportion 1322 is substantially flush with soft tissue 1350 mucosa whenthe retractor member 1320 is not in use.

13I. Lateral (left) and top (right) drawings of tongue 1351 with atissue retractor 1301 (e.g., an LTR) with an elastic sleeve or a band1370 placed over the tongue blade and a shaft 1310 connecting to apartially implanted retractor member 1320. The arrow 1313 shows thedirection of force and tongue base displacement.

13J. Lateral (left) and top (right) drawings of a tongue 1351 with atissue retractor 1301 (e.g., an LTR) anchored by an anchor member 1330in each PGF 1357 and a shaft 1310 passing across the tongue 1351 baseand contacting at portion of a partially implanted retractor member1320.

13K. Lateral (left) and top (right) drawings of a tongue 1351 with afirst tissue retractor 1301 a (e.g., an LTR) anchored beneath the tongueblade 1352 by a first anchor member 1330 a, a first shaft 1310 a passesthrough the tongue blade to a first retractor member 1320 a. The firstretractor member 1320 a acts as a modified anchor member, which is thesecond anchor member 1330 b on the superior surface of the tongue 1351.A second shaft 1310 b passes posteriorly to a semi implanted secondretractor member 1320 b. At portion of the semi implanted secondretractor member 1320 b is implanted in the tongue 1351. The use of afirst tissue retractor 1301 a allows adjustment of tension of the secondtissue retractor 1301 b from the anchor site of the anchor member 1330 alocated beneath the tongue blade 1352.

13L. Lateral drawing of a tongue 1351 with a tissue retractor 1301includes a rigid shaft 1310 that connects an anchor member 1330 belowthe tongue blade 1352 to a retractor member 1320 above the tongue blade1352.

13M. Lateral drawing of a tongue with a sleeve (e.g., a band 1370)reversibly placed over the tongue blade 1352 and the tissue retractor1301 shown in FIG. 13L is rotated forward by the band 1370. The band1370 pushes and rotates the retractor member 1320 forward and pushes theanchor member 1330 forward. The counterforce that allows pushing of thetissue retractor 1301 comes from resistance of the tongue 1351 beingcompressed by the band 1370.

FIG. 14. The Superior Pharyngoglossal Fold (PGF).

14A. Side view of the upper airway showing the area of the tongue wherethe PGF inserts. A smaller superior region is of particular significanceas it receives overlapping insertions of muscles connecting to the softpalate and lateral pharyngeal walls, including but not limited to thepalatoglossus and superior pharyngeal constrictor muscles.

14B. Side view of tongue in relation to mandible with the area ofsuperior PGF attachment marked.

14C. The palatoglossus muscle is shown connecting the soft palate to thesuperior PGF.

14D. The superior pharyngeal constrictor muscle connects the pharyngealwalls to the superior PGF.

14E. Schematic showing that retraction force of the PGF is dispersed tothe tongue base, soft palate, and lateral pharyngeal walls.

FIG. 15. Pharyngoglossal Fold embodiments

15A. Drawing showing the posterior collapse of the tongue 1551 and itseffects on airflow 1569 through the airway.

15B. A retractor member 1520 at the PGF 1557 (i.e., the first PGF) and ashaft 1510 that passes across the frenulum 1560 to a retractor in theother PGF (i.e., the second PGF). The shaft 1510 can pass anteriorly toa dental anchor or other anchor in the patient's oral cavity.

15C. A retractor member 1520 in the PGF 1557 and a shaft 1510 passingthrough the tongue 1551 tissue to emerge and connect to a modifiedanchor 1531. An alternative embodiment shows the retractor member 1520in the PGF 1557 passes through the tongue 1551 tissue through the floorof the mouth 1576 to an external anchor 1532 resting on the skin 1590.

15D. An implanted tissue retractor 1501 (e.g., an LTR) with a retractormember 1520 in or near the PGF 1557 and a shaft 1510 passing throughtongue 1551 to an anchor member implanted in the genioglossus muscle oran anchor member implanted in structures located in or at the floor ofthe mouth 1576.

15E. A tissue retractor 1501 (e.g., an LTR) with a retractor member 1520in the superior PGF 1557 a and an anchor member 1530 in the inferior PGF1557 b. Arrow 1513 shows the inferior displacement of the tongue base1553.

15F. A retractor member 1520 in the PGF 1557 and a shaft 1510 passingthrough the tongue 1551 to an anchor member 1530 on the superior surfaceof the tongue 1551.

FIG. 16. Pharyngoglossal Fold embodiments.

16A. A retractor member 1620 at the tongue base 1653 is connected by twosub-mucosal shafts 1610 to anchor members 1630 disposed in front of eachPGF 1657.

16B. A sub-mucosal shaft 1610 connects two anchor members 1630 eachanchor member 1630 is in front of each PGF 1657.

16C. Two implanted anchor members 1630 are in or near the PGFs 1657 andthe first anchor member 1630 is connected to the second anchor member1630 by a sub-mucosal shaft 1610.

16D. Magnets 1691 implanted in or near each PGF 1657 are connected by asub-mucosal shaft 1610. The tissue retractor is “loaded” by exposing theimplanted magnets 1691 to an external magnet that is attracted to themagnets 1691.

16E. Two figures on the left show a magnet 1691 implanted in a PGF 1657is retracted by a magnet of opposite polarity attached to a modifiedanchor. Two figures on the right show a magnet 1691 enclosed in animplant that has two flanges to keep the implant in place within the PGF1657.

16F. Left, a schematic of a tissue retractor 1601 that has an anchormember 1630 that can be a dental type modified anchor. The anchor member1630 is a clasp that reversibly attaches to teeth 1698 as shown onright. A shaft 1610 of variable length attaches to a retractor member1620 or to a coupling mechanism that in turn connects to an implantedretractor member. The implanted retractor member may be a magnet ormechanical mechanism. Right, Drawing of tongue 1651 and mandible 1668seen from above. Two embodiments of the dental modified anchor areshown: in the bottom embodiment, the retractor member is a magnet thatcouples to an implanted magnet as shown in the two figures on the leftof FIG. 16E; in the top embodiment, the shaft ends with a magnet thatcouples to a reversible magnetic implant as shown in the two figures onthe right of FIG. 16E

FIG. 17. Soft Palate embodiments.

17A. View of the mouth showing the soft palate and palatoglossal folds(Henry Gray. Anatomy of the Human Body. 1918).

17B. Same view as FIG. 17A but with mucosa removed showing theunderlying muscles (right side) and the nerve and blood supply (leftside).

17C. View of the left lateral pharyngeal wall area after mid-sagittalsection of FIG. 17B. The tongue is retracted inferiorly.

Four positions for placement of tissue retractors are shown, in each ofthe four positions an anchor member 1730 is positioned in the superiorPGF:

Position 1) the shaft passes next to palatoglossus muscle around thetonsil, the retractor rest against lateral edge of soft palate. Thisembodiment increases the lateral velopharyngeal area.

Position 2) the shaft travels within the palatoglossus muscle, theretractor is near the midline soft palate. This embodiment increasesmedial velopharyngeal airspace.

Position 3) the shaft passes through the palatoglossus muscle, thepalatine tonsil, and the palatopharyngeus muscle, the retractor restsagainst the posterior wall of the soft palate. This embodimentcompresses and permanently remodels the palatine tonsil.

Position 4) the shaft passes 1 cm under the tongue base mucosa and theretractor rests against tongue base. This position of tissue retractorplacement can be employed for tensing the tongue base.

FIG. 18. Tonsillar Fold embodiments

18A. The tissue retractor 1801 has a retractor member 1820 on theposterior surface of posterior tonsillar fold, at least a portion of theshaft 1810 is inside the tissue of the soft palate, the anchor member1830 is on the anterior surface of anterior tonsillar fold. This isemployed for compression of the palatine tonsil.

18B. A retractor member 1820 in the superior Palatoglossus fold and ananchor member 1830 in the inferior Palatoglossus Fold or PGF.

18C. The tissue retractor 1801 is implanted within the palatoglossusmuscle.

18D. The anchor member 1830 at lateral aspect of soft palate, at least aportion of the shaft 1810 is inside the tissue of the soft palate, theretractor member 1820 midline of the soft palate.

18E. The tissue retractor 1801 retractor member 1820 is on the innersurface of the palatoglossal fold and the anchor member 1830 is amodified dental anchor that couples to a patient's tooth 1898.

18F. The tissue retractor 1801 retractor member 1820 is posterior thetonsillar fold, at least a portion of the shaft 1810 is inside thetissue of the soft palate, and the anchor member 1830 is anterior thetonsillar fold.

FIG. 19. Soft palate embodiments

19A. Top (left) and lateral (right) drawings of the soft palate theanchor member 1930 is in the superior pharyngeal side 19661 and theretractor member 1920 is in the inferior oral side 19662.

19B. Top (left) and lateral (right) drawings of the soft palate theretractor member 1920 is in the superior oral side 19662 and the anchormember 1930 is in the inferior pharyngeal side 19661.

19C. Top (left) and lateral (right) drawings of the soft palate. Abolster 1940 is added in front of the anchor member 1930 to load thetissue retractor 1901. Note the indentation and rotation of the softpalate 1966.

19D. Top (left) and lateral (right) drawings of the soft palate. Atissue retractor 1901 is totally implanted in the soft palate 1966.

19E. Top (left) and lateral (right) drawings of the soft palate. Aretractor member 1920 and an opposing anchor member 1930 are disposedthrough the soft palate 1966.

19F. Top (left) and lateral (right) drawings of the soft palate. Thetissue retractor 1901 provides an attachment for retainers (e.g., one ormore bands 1970) that lift edge of soft palate 1966.

FIG. 20. Veterinarian embodiments—Shown are embodiments of thisinvention for equine dorsal displacement of the soft palate 2066.

20A. Normal configuration of the horse upper airway during exercise.Note that the soft palate 2066 overlaps and interlocks the epiglottis2063 of the larynx to provide an open conduit for airflow 2069.

20B. In dorsal displacement of the soft palate (DDSP) in horses the softpalate 2066 is dislodged from its locked position and obstructs theairway from airflow 2069. This is believed to be caused by the backwardmovement of the tongue base 2053.

20C. An embodiment of a tissue retractor 2001 (i.e., an LTR) for thiscondition. The shaft 2010 reaches through the mandible 2068 to anadjustable anchor member 2030 in front of the mandible 2068.

20D. Another embodiment where the shaft 2010 connects to an anchormember 2030 on the tongue 2051 surface which is reversibly attached tothe bit 2067 of a bridle during exercise.

20E. An embodiment that employs a tissue retractor 2001 to directlyoppose dislodging the soft palate 2066 from its normal position. Ananchor member 2030 in front of the soft palate 2066 passes backward andthen through the epiglottis 2063 to a retractor member 2020 on thelaryngeal surface of the epiglottis 2063.

20F. Another view of the of the soft palate 2066 and epiglottis 2063employing the tissue retractor 2001 depicted in FIG. 20E.

20G. In an alternative embodiment a tissue retractor 2001 b, 2001 c(e.g., an LTR) passes from the PGF's 2057 to the lateral aspect of thesoft palate 2066. The view is from the front and the tongue 2051 istransparent. For comparison, the midline embodiment described in FIG.20E is also shown with the anchor member 2030 of the tissue retractor2001 a in the soft palate 2066.

FIG. 21. Non-invasive PGF retractor

21A. Schematic of airway obstruction to airflow 2169 due to backwardcollapse of the tongue 2151.

21B. PGF 2157 retraction employs a soft “hook” that retracts the PGF2157 forward and thereby retracts the base 2153 of the tongue 2151, thesoft palate 2166 and the pharyngeal walls 2165.

21C. Close up view of a portion of a “hook” shaped retractor member2120.

21D. Close up view of a clamp 2193 that remains in place surrounding thePGF 2157 by compressing the soft tissue of the PGF 2157 with its arms.The clamp 2193 would always be available for hooking up with, forexample, a shaft and because it stays in position it would avoid causingthe gag reflex each time it is placed.

21E. An embodiment of a clamp 2193 surrounding the PGF 2157 wherecompression is performed by two magnets 2191, 2192 of opposing polarity.

21F. Embodiment from 21E where the clamp's 2193 magnets 2191, 2192 arealso used to couple to a shaft 2110A where the clamp 2193 acts as aretractor member 2030 that is attached by the shaft 2110A to a modifiedanchor.

21G. Drawing of two tissue retractors 2101 reversibly placed in apatient's mouth and the effect of the two tissue retractors 2101 on thetongue base 2153 (dotted line).

21H. Close-up view of a tissue retractor 2101 having a hook shapedanchor member 2130.

FIG. 22. Non-invasive retraction, clip embodiment.

22A. Side view of clamp 2293 on soft tissue fold. One method ofreversibly attaching to the fold is to compress the tissue by the endsof the clamp 2293.

22B. Side view of a clamp 2293 having magnets 2291, 2292 of oppositepolarity. The magnets attraction provides sufficient force for a stableclamp 2293 position and a shaft is unnecessary to maintain the clamp2293 in position on the mucosal fold 2259.

22C. Front view of clamp 2293 on a soft tissue fold. The shaft 2210connection between the arms of the clamp 2293 can serve to retract theedge of the mucosal fold 2259.

22D. Two clamps 2293A, 2293B are used to provide protraction(lengthening) of tissue, protraction can have a useful effect onstructures that benefit from stiffening such as the soft palate and thetongue base.

22E. A clamp 2293 on anterior tonsillar pillar attached via a shaft 2210to a dental anchor 2230 that is reversibly anchored to a tooth 2298.

22F. A clamp 2293 on posterior tonsillar pillar attached via a shaft2210 to a dental anchor 2230 that is reversibly anchored to a tooth2298.

22G. A clamp 2293 on the edge of soft palate attached via a shaft 2210to a dental anchor 2230 that is reversibly anchored to a tooth 2298.

22H. Two clamps 2293A, 2293B attached by a shaft 2210C that retract thepharyngeal wall toward the aryepiglottic fold, thus stiffening thelateral pharyngeal wall.

FIG. 23. Non-invasive protraction and vacuum

23A. Side view. Floor of mouth 2376 is marked by a checkered patternthat extends from the mandible 2368 to the hyoid bone 2377.

23B. Front view. Floor of mouth 2376 connects to the bottom of each sideof the mandible 2398.

23C. Top view. Tongue 2351 is transparent and triangular root 2349 oftongue can be seen. The anterior extension of the root 2349 is thegenioglossus muscle 2363 (seen in FIGS. 23A and 23B) insertion into themandible 2398.

23D. A bolster 2340 is pushed downward and slightly anterior by a shaft2310 exerting a protracting force. Note the indentation of the floor ofmouth 2376 and the altered position of the tongue 2351 and the PGF 2357.

23E. The floor of mouth 2376 is depression by the bolster 2340 isreflected by decreased height of tongue 2351 surface.

23F. The bolster 2340 is seen from above. Note the anterior displacementof the base of the tongue 2351.

23G. Side view. A vacuum device 2347 is a retractor member 2320 appliedto the lateral tongue 2351. The vacuum device 2347 is positioned belowthe tongue 2351 adjacent the floor of mouth 2376 and the PGF 2357.

23H. Front view. A vacuum device 2347 is employed as a retractor member2320 that displaces tongue 2351 tissue. Tongue 2351 tissue displacementis reflected by the decreased height of the tongue 2351 surface.

23I. Top view. A vacuum device 2347 is employed as a retractor member2320 that displaces tongue 2351 tissue resulting in anteriordisplacement of the base of the tongue 2351 that avoids obstruction ofthe airway due to collapse of the tongue 2351 toward the soft palate2366 (see FIG. 23G).

23J. A view of another vacuum device 2347 employed as a tissueretractor.

23K. A close up view of the vacuum device 2347 of FIG. 23J employed as atissue retractor.

23L. A close up view of the vacuum device 2347 of FIG. 23K employed as atissue retractor.

23M. A close up view of another embodiment of a vacuum device 2347.

23N. A close up view of another embodiment of a vacuum device 2347.

The term “subject” as used herein includes animals of mammalian origin,including humans. Anatomical terminology used to describe position andorientation as used herein can best be defined by the followingdescription:

When referring to animals, that typically have one end with a head andmouth, with the opposite end often having the anus and tail, the headend is referred to as the cranial end, while the tail end is referred toas the caudal end. Within the head itself, rostral refers to thedirection toward the end of the nose, and caudal is used to refer to thetail direction. The surface or side of an animal's body that is normallyoriented upwards, away from the pull of gravity, is the dorsal side; theopposite side, typically the one closest to the ground when walking onall legs, swimming or flying, is the ventral side. On the limbs or otherappendages, a point closer to the main body is “proximal”; a pointfarther away is “distal”. Three basic reference planes are used inzoological anatomy. A “sagittal” plane divides the body into left andright portions. The “mid-sagittal” plane is in the midline, i.e. itwould pass through midline structures such as the spine, and all othersagittal planes are parallel to it. A “coronal” plane divides the bodyinto dorsal and ventral portions. A “transverse” plane divides the bodyinto cranial and caudal portions.

When referring to humans, the body and its parts are always describedusing the assumption that the body is standing upright. Portions of thebody which are closer to the head end are “superior” (corresponding tocranial in animals), while those farther away are “inferior”(corresponding to caudal in animals). Objects near the front of the bodyare referred to as “anterior” (corresponding to ventral in animals);those near the rear of the body are referred to as “posterior”(corresponding to dorsal in animals). A transverse, axial, or horizontalplane is an X-Y plane, parallel to the ground, which separates thesuperior/head from the inferior/feet. A coronal or frontal plane is anY-Z plane, perpendicular to the ground, which separates the anteriorfrom the posterior. A sagittal plane is an X-Z plane, perpendicular tothe ground and to the coronal plane, which separates left from right.The mid-sagittal plane is the specific sagittal plane that is exactly inthe middle of the body.

Structures near the midline are called medial and those near the sidesof animals are called lateral. Therefore, medial structures are closerto the mid-sagittal plane, lateral structures are further from themid-sagittal plane. Structures in the midline of the body are median.For example, the tip of a human subject's nose is in the median line.

Ipsilateral means on the same side, contralateral means on the otherside and bilateral means on both sides. Structures that are close to thecenter of the body are proximal or central, while ones more distant aredistal or peripheral. For example, the hands are at the distal end ofthe arms, while the shoulders are at the proximal ends.

DEFINITIONS

“Anchor” refers to a component of the device that mechanically couplesto a site that is substantially immobile or substantially fixed relativeto the retractor.

“Deformation” refers to an abnormal change in the shape of upper airwaysoft tissue structures. This deformation can be due to negative pressureacting on relaxed upper airway structures during sleep causing them tonarrow the upper airway. Most preferably this soft tissue can be thetongue curve.

“Frenulum” refers to the vertical anterior edge of the genioglossusmuscle. The frenulum passes from the floor of the mouth up to thecenterline of the underside of the tongue. The frenulum marks theboundary between the tongue blade and tongue body.

“Frenulum area” refers to the genioglossus muscle and its surroundingmucosa.

“Loaded” refers to a tissue retractor (e.g., an LTR) that can have itstension adjusted such that it has minimal tension during the wakinghours (e.g., “Unloaded”) and higher therapeutic levels of tension duringthe sleeping hours (e.g., “Loaded”). The loaded configurationcorresponds to the higher therapeutic levels.

“Modified anchor” is an additional component that allows attachment ofthe permanent anchor of the tissue retractor. In some embodiments themodified anchor allows the patient to adjust tension in the tissueretractor, specifically to increase tissue retractor tension during thesleeping hours (e.g., at night) and to reduce tissue retractor tensionduring the waking hours (e.g., during the day).

“Palate retractor” refers to a complete device used for the preventionof soft palate deformation.

“Permanent anchor” refers to an anchor component of a tissue retractorthat remains on the tissue retractor for the duration of theimplantation. In some embodiments, the permanent anchor prevents theanterior end of the shaft from slipping back into tissue (e.g., tonguetissue). In certain embodiments the permanent anchor also serves toconnect to a “modified anchor” when a modified anchor is used.

“Pharyngeal wall retractor” refers to a complete device for theprevention of pharyngeal wall deformation.

“Protract” means to lengthen or push apart.

“Reverse deformation” refers to a change in soft tissue shape caused bythe tissue retractor. In some embodiments reverse deformation refers torestoring a deformed structure to its normal shape. In other embodimentsreverse deformation refers to an indentation of soft tissue in a givenarea due to the action of a tissue retractor.

“Sleep breathing disorders” refers to all breathing disorders occurringduring sleep including but not limited to obstructive sleep apnea,obstructive sleep apnea syndrome, upper airway resistance syndrome, andsnoring.

“Tongue base” refers to the part of the tongue posterior to the tonguecurve. In anatomical terms the line of demarcation of the tongue base isthe circumvalatte papillae, a grossly visible line of raised tasteorgans on the superior surface of the tongue.

“Tongue blade” refers to the part of the tongue anterior to thefrenulum. It is covered by mucosa on its top, sides and undersurface.

“Tongue body” is the mid part of the tongue located between the tongueblade and tongue base.

“Tongue boundary” or “boundary” is the inferior surface of the tonguebody and base. The genioglossus muscle inserts onto a large part of theboundary.

“Tongue curve” refers to the area of the tongue where its superiorsurface curves from a horizontal orientation (tongue body and blade) toa vertical orientation (tongue base). Preferably tongue curve refers tothe soft tissue in this area between the mucosal covering of the tongueand the connective tissue boundary where the genioglossus muscleattaches.

“Tongue retractor” refers to a complete device used for the preventionof tongue deformation. In some embodiments it includes a retractorconnected to a shaft which in turn is connected to an anchor.

“Laryngeal retractor” refers to a complete device for the prevention oflaryngeal soft tissue deformation.

“Retractor” or “retractor head” or “retractor member” refers to a partof an overall tissue retractor. The retractor physically interacts withsoft tissue, either directly or indirectly, to prevent it fromdeforming. In certain embodiments the retractor head is a disc locatedon an external surface of the tongue, in other embodiments the retractorhead is an inflatable balloon, in other embodiments the retractor headmay have curved parts that act like hooks, in other embodiments theretractor head may be a flexible wire passing through the tissue, or insome embodiments the retractor is totally implanted within tissue.

“Shaft” refers to that part of the tissue retractor that attaches to theretractor head (e.g. the retractor member) and serves to connect it tothe anchor member. The shaft may be one or more of rigid, flexible,solid, hollow, one piece, or multiple linked pieces.

“Unloaded” refers to a tissue retractor that exerts little or notension. This is usually meant as the configuration during the wakinghours (e.g., during the day). In comparison, the tissue retractor isloaded to therapeutic levels during the sleeping hours (e.g., a night).

EXAMPLES 1. Retractor Member (FIG. 6)

Disclosed here, referring to FIG. 6A, is a tissue retractor 601, whichincludes a retractor member (i.e., the retractor head 620), a shaft 610,and an anchor member. One end of the shaft 610 connects to the retractormember 620 and the other end of the shaft 610 connects to an anchormember (not shown). Referring to FIGS. 6B-6E, the tissue retractor 601retractor member 620 is inserted into a tissue 650 by a needle 635 andthe tissue retractor 601 automatically deploys to its working shape.

Referring now to FIG. 6E, the retractor head 620 prevents at least aportion of the tissue 650 (e.g., the tongue base) from deforming. Forexample, in one embodiment, the deployed tissue retractor 601 has aretractor head 620 that prevents deformation of at least a portion ofthe tongue base to prevent obstruction of the patient's airway.

The preferred qualities for a retractor head 620 that rests upon tissue650 (e.g., tongue base mucosa) are that its depth is minimal so that itis not noticeable to the patient yet its surface area is large enough toprovide sufficient counterforce. The counterforce is a pressure thatprevents deformation of at least a portion of the tissue 650 (e.g.,tongue base mucosa). Integral to its design is the delivery device(e.g., the needle 635) used to insert the tissue retractor 601 (e.g.,the LTR). In one embodiment, the entire device (e.g., the deliverydevice, the needle 635, and the tissue retractor 601 disposed on theneedle 635) is inserted from the anterior tongue with minimalinstrumentation used at the back of the tongue. Therefore the retractorhead 620 preferably automatically deploys to its working shape (i.e.,FIG. 6E) after being implanted by a needle 635 inserted from the frontof the tongue.

Part of this aspect of the invention includes improvements in the designof the retractor head 620 that allow it to be easily inserted. Incertain embodiments, this insertion would be by a needle 635. Thereforeone embodiment of this invention is a retractor head 620 that foldswithin a needle 635 but deploys to its working shape after insertion.Many mechanisms are known that allow a device to be minimized forinsertion in the body, non-limiting examples include nitinol wire, highpressure balloons, and spring mechanisms. These mechanisms work well butadd complexity and unnecessary expense.

In one embodiment, the retractor component, the retractor head 620, isoval shaped (10 mm long, 5 mm wide, 2.5 mm deep) and is molded togetherwith the shaft 610 (1 mm in diameter) as a single piece from moderateconsistency medical grade silicon (Shore 80 durometry, Nusil, Ca) (FIG.6A). The retractor head 620 is tilted 75° in relation to the shaft 610.When the tissue retractor 601 is threaded into the needle bore 645 of aneedle 635 (FIGS. 6B-6C) one side of the oval retractor head 620 extendsout of the needle 635 port and projects at a 15° angle relative to theoutside wall of the needle 635. When the needle 635 is inserted throughtissue 650 this extension of the retractor head 620 is pushed flushagainst the needle 635 wall and causes a minimum increase in the needle635 profile (FIG. 6C). However, immediately after the needle 635 passesthrough tissue 650 (e.g., mucosa) the retractor member 620 reverts toits extended position (FIG. 6D). The needle 635 is pulled back andremoved from the tissue 650 causing the retractor member 620 to catch atleast a portion of the tissue 650 (i.e., the mucosa), which prevents thetissue retractor 601 from being withdrawn along with the needle 635 fromthe tissue 650. After the needle 635 is removed, minor tension on theshaft 610 causes the retractor head 620 to rotate into proper positionand lay flush against the mucosa (FIG. 6E).

The practical advantage of this invention is that the physician canrapidly and easily insert and withdraw the needle 635 and the tissueretractor 601 device automatically settles into its proper position whenthe retractor head 620 deploys and contacts the tissue 650.

2. Shaft Member.(FIG. 7)

Referring now to FIGS. 7A-7C, disclosed here is a modified shaft 710that adapts its length to avoid interfering with normal movements of thetongue 751 (e.g., the tongue base).

The counterforce exerted against the back of the tongue 751 base ispreferably present during sleep but not during the awake state. Morepreferably, the counterforce is present when the tongue 751 is relaxedand vulnerable to posterior collapse, but not during speech andswallowing. During swallowing the tongue base moves rapidly backwardabout 1 cm to contact the back wall of the pharynx. The tongue basemoves similarly during some speech movements, albeit with much lessforce. It is desirable that these swallowing and speech movements arenot impaired.

In one embodiment of the shaft 710 the section within the tongue 751 isa distensible portion 711, one non-limiting example being a balloon.Compression of the balloon portion 711 of the shaft 710 allows the shaft710 to lengthen. During swallowing the tongue 751 contracts forcefullyaround the shaft 710. This contraction squeezes the balloon portion 711and lengthens it, thereby displacing the retractor head 720 superiorly.As the tongue base moves superiorly in the area of the retractor head720 during swallowing, the compression exerted on the shaft 710 causesthe shaft 710 to lengthen proportionally and prevents the retractor head720 from exerting unneeded counterforce on the tongue base duringswallowing. However, the ability to exert the proper amount ofcounterforce when the tongue 751 is relaxed is maintained. The amount ofdistensibility is from about 0.01 cm to about 10 cm, or about 1 cm.

The decrease of counterforce by the retractor head 720 during swallowingand speech can be accomplished by many known mechanical andelectromechanical mechanisms. Those skilled in the art can readilyappreciate that the invention can have multiple embodiments.

3. Anchor Member: Bolster, Dental, Implanted (FIGS. 8,9,10)

Disclosed here are modified anchors that allow reversible loading of animplanted tissue retractor (i.e., LTR).

Referring now to FIGS. 8A-8H, the anchor 830 is the anterior componentof the tissue retractor 801 (i.e., LTR) that resists displacement of theshaft 810 and retractor head 820. In a preferred embodiment the tissueretractor 801 (i.e., LTR) is under little or no tension during the day(unloaded state) and is adjusted to exert tension at night (loadedstate). In this embodiment the anchor 830 merely prevents the anteriorend of the shaft 810 from being pulled back into tongue tissue 851. Forthis purpose a small flange is sufficient. However, at night whenfurther retractor counterforce is desired, the anchor 830 can bereplaced, modified, or supplemented; collectively referred to as amodified anchor.

One embodiment of a modified anchor is a bolster 840 that is interposedbetween the permanent anchor 830 and the tongue 851. This bolster 840either lengthens the shaft 810, or if the shaft 810 is set at a fixedlength it increases the total volume compressed between retractor head820 and shaft 810. In either case the addition of the modified anchor(e.g., the bolster 840) causes a reversible increase in retractor 820counterforce.

In one embodiment of the modified anchor the bolster 840 is composed ofsilicon gel and is shaped as a V (FIGS. 8A-8C). The concave innersurface of the ‘V’ adapts to the wedge shape of the frenulum 860, thestructure underneath the tongue blade 852. The intent of the ‘V’ shapeis to spread the retracting counterforce across a wide surface area ofthe frenulum 860. In the center of the anchor 830 bolster 840 is aconduit through which the permanent anchor 830 and shaft 810 isthreaded. In one embodiment the conduit is a cleft 848 beginning in thecenter of the top center edge. This cleft 848 is about the width of theshaft 810 but less then that of the permanent anchor 830. The patientcan reach under the tongue 851 and pull the permanent anchor 830 forwardin direction 899 (FIGS. 8D-8F), slip the bolster 840 under the tongue851, lay the shaft 810 into the cleft 848, and release the permanentanchor 830. The permanent anchor 830 then securely rests against thefront surface of the cleft 848 and exerts force. The cleft 848 may bereinforced with a harder grade of silicon or another biocompatiblematerial.

Another embodiment of this invention is to secure the permanent anchorto a modified bolster that is permanently or reversibly attached to theteeth, a dental anchor (FIGS. 9A-9E). Many devices that attach to teethare known in the art. A non-limiting example is ‘T’ shaped. The topcross bar of the “T” 932 rests against the front surface of the lowerincisor teeth 998. The initial section of the vertical line of the “T”932 is thin enough to pass between the front two incisor teeth 998. Thisvertical part widens to allow the retractor head 920 to be threaded. Thefinal part of the “T” 932 narrows again to about the width of the shaft910. This mechanism allows the anchor 930 to be easily and reversiblyattached to the dental bolster (FIGS. 9A-9B).

Another embodiment is a dental anchor 931 optimized for use on the sidesof the mouth rather then the front. This embodiment (FIGS. 9C-9D)anchors 931 to a molar or premolar tooth 998 or neighboring structures.This embodiment is advantageous due to the short distance between thetissue retractor (e.g., an LTR) and the modified anchor, its position onthe lateral aspect of the tongue 951 is unlikely to interfere withnormal tongue function, and it is easily accessible for placement,adjustment and removal by patient and physician.

In a further embodiment a dental prosthesis is used as an anchordisposed in the soft palate, the palatoglossal folds, thepharyngoglossal folds, the tongue, or other upper airway sites to anchorto a tissue retractor. Dental prostheses are well known in the dentalarts. In some embodiments, dental prosthesis provide a wide and stableplatform for anchoring embodiments of a tissue retractor. Furtherembodiments can take advantage of the large size and position of theseprostheses.

Referring now to FIG. 9E, in one embodiment, the anchor member 903 is apalatal prosthesis 972. The palatal prosthesis 972 is disposed on aportion of the soft palate 966. For example, the palatal prosthesis 972may be disk disposed on a surface of the soft palate 966. Alternatively,the palatal prosthesis 972 may be a hook disposed inside a portion ofthe soft palate 966. The palatal prosthesis 972 may be a suction cupdisposed on a portion of the soft palate 966. In one embodiment, atissue retractor 901A includes a retractor member 920A disposed onanother portion of the soft palate 966, the anchor member 930 is theabove described palatal prosthesis 972, and a shaft 910A is disposedbetween the retractor member 920A and the anchor member 930. Theplacement of the retractor member 920A and the palatal prosthesis 972can be selected to enlarge the airway in the area around the soft palate966. In another embodiment, a tissue retractor 920B is disposed on thesurface of the tongue 951. For example, the tissue retractor 920B is atongue stud on the surface of the tongue 951. The tongue stud may bepart of a conventional tongue piercing. The shaft 910B connects thetongue stud to the palatal prosthesis 972. The shaft 910B can have anend that connects to the tongue stud retractor member 920B by encirclingor looping about all or a portion of the tongue stud. The shaft 910B canbe an elastic material. The retractor member 920B is pulled toward thedirection of the palatal prosthesis 972 thereby enlarging the airwaybehind the tongue base 953. In one embodiment, a retractor member 920Cis disposed in the floor of the mouth 976. A shaft 910C is disposedbetween the palatal prosthesis 972 and the floor of the mouth 976.

In one embodiment, the retractor member 920C provides a protractionforce that is directed to push the floor of the mouth 976 in thedirection opposite the palatal prosthesis 972. More specifically, in oneembodiment, the protraction force is directed inferiorly. The protectionforce can be provided by the shaft 910C. The shaft 910C can be a rigidmaterial. Alternatively, the shaft 910C is made from a material thatlengthens. The shaft 910C can have passive properties that enable it tolengthen, for example, the shaft 910C can include a compressed elastic,a compressed spring element, or a nitinol wire, for example. In oneembodiment, the shaft includes a pressurized fluid, an electric motor orother means that exert a lengthening force. For example, the shaft 910Ccan include two hollow tubes with one tube sliding within the other tubeto change the overall tube length. In another embodiment, the shaft 910Cis a fixed length that is longer than the distance between the palatalprosthesis 972 and the floor of the mouth 976.

In one embodiment, a bolster is disposed between the shaft 910C and thefloor of the mouth 976 such that the shaft 910C does not contact mucosaon the floor of the mouth 976. The bolster improves the patient'scomfort. In one embodiment, the bolster feels soft and/or pliable and isbiocompatible. The bolster can range in size from a 0.1 cm long by 0.1cm wide square or to the entire surface area of the floor of the mouth.In one embodiment, the bolster is 0.5 cm wide and 1.5 cm long. Suitablebolsters are sized to fit on the floor of mouth 976 adjacent thepatients tongue 951. The bolster may be positioned along the floor ofthe mouth from the front wall of the PGF 967 to the back wall of themandible 968 behind the lower incisor teeth. In one embodiment, theshaft 910C exerts force to the area of the floor of mouth 976 directlyinfront of the PGF 967 such that the protraction force of the shaft 910Cpushes a bolster such that the force is transmitted to the tongue base953.

In one embodiment, a retractor member 920D is disposed in the PGF 967. Ashaft 910D is disposed between the palatal prosthesis 972 and theretractor member 920D. The shaft 910D may be a rigid material or it maybe a material that lengthens when exposed to a force. The shaft 910Dexerts force by protraction or inferior force on the PGF 967. Becausethe PGF 967 is attached to the tongue base 953 the force exerted by theshaft 910D on PGF 967 is directly transmitted to the tongue 951, whichcauses protraction of the tongue base 953 thereby opening the patient'sairway.

Referring still to FIG. 9E, in one embodiment, a tissue retractor fortreatment of a breathing disorder includes an anchor member 930 sizedfor placement on or in a patient's soft palate and a shaft 910 having afirst end and a second end, the first end connected to the anchor member930. The tissue retractor also includes a retractor member 920 connectedat or near the second end of the shaft 910. At least one of the shaft910 and the retractor member 920 is positioned on or in a soft tissuelocated in the patient's oral cavity or pharynx. The anchor member 930,the shaft 910, and the retractor member 920 exert a force that preventsdeformation of at least a portion of the soft tissue to preventobstruction of the patient's airway. The force may be a retraction forceor, alternatively, a protraction force. The retractor member 920 may bepositioned on or in the soft palate, the pharyngoglossal fold, the floorof mouth, or the tongue, for example. In one embodiment, the retractormember 920 is a tongue stud on the surface of a tongue 951.

A method for treatment of a breathing disorder can include positioning apalatal prosthesis 972 on or in the patient's soft palate, positioning aretractor member 920 on or in a soft tissue located in the patient'soral cavity or pharynx, connecting a first end of a shaft 910 to thepalatal prosthesis 972, and connecting a second end of the shaft 910 tothe retractor member 920. At least one of the palatal prosthesis 972,the shaft 910, and the retractor member 920 interact to exert a forcethat prevents deformation of at least a portion of the soft tissue toprevent obstruction of the patient's airway Optionally, as discussedabove, to maximize adjustability, a bolster may be inserted between theend of the shaft 910 and the patient's tissue, for example, the bolstermay be inserted between the shaft 910 and the floor of the mouth 976. Atleast one of the palatal prosthesis 972, the shaft 910, and theretractor member 920 interact to exert one of a retraction force or aprotraction force that prevents deformation of at least a portion of thesoft tissue to prevent obstruction of the patient's airway.

Those skilled in the art can understand that a variety of electrical ormechanical mechanisms could be incorporated within these dentalprosthesis. As a non-limiting example, an electrical motor could be usedto control the force applied to coupled tissue retractors at multiplelocations in the upper airway.

Referring now to FIGS. 10A-10C, in still another embodiment, themodified anchor 1031 is partially implanted into the floor of the mouth.In one embodiment of this invention a puncture is made across thefrenulum 1060 or soft tissue structures of the floor of the mouth. Thefrenulum 1060 has a central tendon 1067. Generally, the frenulum area1060B includes the whole genioglossus 1063 and its surface mucosa. Thefrenulum 1060A includes the front edge of the frenulum area 1060B. Inone embodiment, a shaft (e.g., a flexible shaft) is threaded through thepuncture and the ends are connected to create the modified anchor 1031,a ring like structure. The modified anchor 1031 is securely fixed withintissue (FIG. 10). In one embodiment, during sleeping hours (e.g., atnight) the modified anchor 1031 is reversibly attached to the permanentanchor of a tissue retractor and the modified anchor 1031 is disengagedfrom the permanent anchor of the tissue retractor during waking hours(e.g., in the morning).

4. Frenulum Area Embodiments

Referring now to FIGS. 11A-11E, disclosed are methods and devices forretracting or preventing deformation of the tongue base 1153 byretracting the genioglossus muscle 1163 or the boundary fascia 1161 uponwhich the genioglossus muscle 1163 inserts (this area is collectivelyreferred to as the frenulum area 1160).

It has been unexpectedly found that the shaft 1110 of the tissueretractor 1101 (i.e., an LTR) can be safely passed across theundersurface of the tongue 1151. The undersurface of the tongue 1151contains the frenulum area 1160, which is the mucosa covering thegenioglossus muscle 1163. Thus, this under tongue 1151 tissue containsthe genioglossus muscle 1163 and its anterior edge is the frenulum 1160(FIGS. 11A-11B). A central tendon 1167 is substantially in the center ofthe genioglossus muscle 1163 spanning from the mandible 1168 up to theundersurface of the tongue 1151. The genioglossus 1163 muscle originatesfrom the mandible 1168 and has multiple separate muscle fascicles 1164that fan out from a horizontal to vertical angle. The genioglossusfascicles 1164 attach to a layer of connective tissue within the tongue1151 called the boundary 1161 (FIGS. 11A-11B, dotted line). Thegenioglossus fascicles 1164 normally act by exerting force in the axisof the fascicle 1164 onto the part of the boundary 1161 to which thefascicles 1164 are attached. However, even when inactive, the fascicles1164 are mechanically coupled to the tongue boundary 1161 and can exerta force on the tongue 1151 if the fascicles 1164 passively move.Unexpectedly, movement of a portion of the tongue 1151 can be done bypulling these fascicles 1164 perpendicular to their axis (FIG. 11C). Tosimplify the mechanism, in one embodiment, the genioglossus fascicles1164 are lassoed by the tissue retractor 1101, which in one embodiment,is made from the shaft 1110. In one embodiment, the force provided bythe tissue retractor 1101 in the genioglossus 1163 is substantiallyevenly distributed.

There are certain important considerations in placing a retractorthrough the genioglossus 1163: First, the genioglossus 1163 is soft incomparison to the tongue base 1153, therefore, too much force applied ina localized area of the genioglossus 1163 can tear the tissue or causeundesirable tissue remodeling over time, sometimes called the “cheesecutter effect”. However, there is a central tendon 1167 to thegenioglossus 1163 that is very strong. This central tendon 1167 islocated approximately 1 cm from the edge of the frenulum area 1160. Inone embodiment, the tissue retractor 1101 is located anterior to thecentral tendon 1167. In another embodiment, the tissue retractor 1101 isdisposed posterior to the central tendon 1167. Second, the nerve supplyto the genioglossus 1163 passes along the superior aspect of the muscle,therefore the top 0.5 cm of the muscle, the area 1199 directly below thetongue blade 1152, is not a preferable site for the tissue retractor1101 implant.

In one embodiment, the tissue retractor 1101 is a shaft 1110 that has a5 cm length of elastomeric material that is ribbon shaped. The crosssectional dimensions of the shaft 1110 are 0.5 mm depth and 3 mm width.The wider dimension of the width of the shaft 1110 will exert force on awider area of the genioglossus 1163 tissue, because, due to itsdimensions, the shaft 1110 force is dispersed over a wider area then thenarrow edge of the ribbon. The tissue retractor 1101 shaft has a lengththat ranges from about 0.5 cm to about 5 cm, a width that ranges fromabout 0.1 mm to about 10 mm, and a depth that ranges from about 0.1 mmto about 2 mm.

During insertion of the tissue retractor 1101 into the frenulum area1160, the shaft 1110 is attached to a needle and passed through thegenioglossus 1163 muscle approximately 1 cm behind the frenulum 1060A.Referring now to FIG. 11D, the ends of the shaft 1110 are thenreversibly coupled to a modified anchor 1131. The middle section of theshaft 1110 itself exerts anterior retracting force onto the genioglossusmuscle 1163 and acts as a retracting head. One or both ends of the shaft1110 can then be brought forward and secured to a modified anchor 1131.In one embodiment, the location or angle of the modified anchor 1131 isselected to enable a desired position of the tissue retractor 1101 inthe genioglossus muscle 1163. In another embodiment, the modified anchoris a tooth. The position of the tissue retractor 1101 is determinedbased upon the anatomy of the tongue 1151.

This displacement of the genioglossus muscle 1163 is transmitted to thetongue base 1153 causing some degree of concavity in the tongue base1153. The passive movement is preferably in an anterior and inferiordirection. In one embodiment, the displacement of the genioglossusmuscle 1163 is transmitted to the tongue base 1153 and prevents thetongue base 1153 from obstructing the patient's airway. For example, thedisplacement of the genioglossus muscle 1163 prevents the tongue base1153 from falling toward another tissue in the patient's airway.

The advantages of genioglossus muscle 1163 retraction is that thismuscle group is easily accessible beneath the tongue 1151. The tissue ofthe genioglossus muscle 1163 is soft and easily compressed, making iteasy to pierce without complications. The position under the tongue 1151is invisible to others, a quality important for the patient.

A further embodiment of this invention is to pass the tissue retractor1101 (e.g., the LTR) deeper into the tongue 1151 to couple directly tothe boundary layer 1161 (FIG. 11D). The boundary layer 1161 is arelatively firm connective tissue structure which spans the length ofthe body of the tongue 1151. In one embodiment, the boundary layer 1161receives the insertion of the tissue retractor 1101 through thegenioglossus muscle 1163. For example, the shaft is in the genioglossusmuscle 1163 and the anchor member and retractor member loop around someof the boundary layer 1161 to get firm traction. The advantages ofcoupling to the boundary layer 1161 are that it provides a more secureattachment then the genioglossus 1163 itself. However, greater care isneeded for placement of the tissue retractor 1101 device. Specificallythe lingual arteries course just superior and lateral to the boundarylayer 1161 so it is essential that the insertion of the shaft 1110 ofthe tissue retractor 1101 be made medial to the structure of the lingualarteries.

In a further embodiment, a fully implanted tissue retractor 1101 (e.g.,an LTR) connects one site that effects the tongue base 1153 and isanchored at another site that does not. A non-limiting example of afully implanted tissue retractor 1101 is shown in FIG. 11E. Here theposterior boundary layer 1161 a is coupled to the anterior boundarylayer 1161 b. Tension between the two sites displaces the tongue base1153 forward. Simultaneously there is some displacement force exertedaround the anterior boundary site 1161 b, but the displacement force onthe anterior boundary site 1161 b has insignificant effects on normaltongue 1151 function.

The tissue retractor 1101 may have a shape other than the ribbon shapedshaft 1110, however, the tissue retractor 1101 is positioned to takeadvantage to the genioglossus muscle 1163 and/or the behavior of thegenioglossus fascicles 1164. In one embodiment, multiple tissueretractors 1101 are positioned in the frenulum area 1160 to prevent thetongue base 1153 from obstructing the patient's airway.

5. Implanted Tongue Base Retractor (FIG. 12)

Disclosed here are methods of implantation and devices that areimplanted within the tongue and exert highly localized forces to preventmechanical decoupling of tongue base structures.

Chronic implants within the tongue are technically challenging andpotentially dangerous. The tongue is a mobile structure and tonguemovements during swallowing and speech are dependent on this mobility.The tongue has no bones within it and its mechanism of movement isunique among the muscular structures of the body. Most skeletal musclesare attached to bones and movement occurs as mechanical levers. In thetongue, structures cause movement by expanding and changing their shapeand volume. The mechanism is called a muscular hydrostat and is can belikened to a flexible hydraulic system. In addition, the tongue hasextensive nerve and blood supply that can be easily damaged. Moreover,the tongue has a tremendous ability to remodel itself when effected byimplants and other forces. When the tongue remodels itself, it adaptsquickly to pressure exerted on its structure. In response to thepressure exerted on a portion of the tongue by, for example, an implant,the portion of the tongue reshapes to become, for example, thinner inregion of the pressure exerted by the implant. This thinning of thetongue tissue is one reason why many prior art devices have failed, dueto gradual loss of tension or extrusion. Moreover any implant is apotential site for infection and scarring. For these reasons anyinvasive intervention in the tongue must be designed with a detailedknowledge of tongue anatomy and physiology. Therefore, the implantedembodiments disclosed in this invention are carefully designed to beminimally invasive and to focus their effects on critical areas ofpathology without risking interference with normal function.

Referring now to FIGS. 12A-12F, an implanted tissue retractor 1201(e.g., an LTR) disclosed here is a very minimal device implanted intothe tongue 1251 for example, in the tongue base 1253. The implantedtissue retractor 1201 attaches to structures within the tongue 1251 toprevent a portion of the tongue 1251 from obstructing the patient'sairway by, for example, falling toward another structure in thepatient's oral cavity or pharynx. In some embodiments, the at least aportion of the implanted tissue retractor 1201 is made from a flexiblematerial that does not impede the mobility required for normal tongue1251 function.

The tongue 1251 is covered by mucosa and this mucosa has underlyingconnective tissue 1256. The connective tissue 1256 is thickest below thesuperior surface of the tongue 1251. The connective tissue 1256 is acollagenous structure covered in mucosa in the superior layer (SL) 1258of the tongue 1251. This superior surface is intimately connected to theunderlying superior longitudinal muscle. Together the mucosa connectivetissue 1256 and muscle form a superior layer (SL) 1258 that spans thesuperior surface of the tongue 1251 from the tongue tip to its base1253. This superior layer is normally coupled to the underlying middlelayer (ML) 1254 of the tongue 1251, which is largely composed by thetransverse muscle. The transverse muscle originates from a fascial sheetcalled the medial septum (MS) 1255 oriented in the centerline of thetongue (mid-sagittal plane).

Although not wishing to be bound by theory, studies by the inventorsuggest that the vibration during snoring and the stretching duringairway obstruction gradually loosen the attachment of the superior layer1258 to the middle layer 1254. This is reflected by a mechanicaldecoupling, a widening of the superior layer 1258 in the area of thetongue curve, marked by an oval in FIGS. 12D-12E. This mechanicaldecoupling results in a more flaccid and compliant tongue base 1253 thatdeforms more easily when the pressure in the airway decreases, therebymaking the patient susceptible to sleep apnea and other sleep breathingdisorders.

In one embodiment (see, FIGS. 12C and 12F) of the invention a very smalltissue retractor 1201 (e.g., an LTR) is inserted at the curve of thetongue base 1253 to correct the mechanical decoupling of the tonguelayers. In one embodiment, the tissue retractor 1201 (e.g., an LTR) issymmetrical with an arrowhead shaped retractor head and an arrowheadshaped anchor. Each end of the tissue retractor 1201 (e.g., an LTR)mechanically hooks into soft tissue. Preferably, the tissue retractor1201 is connected between the connective tissue fascia of the mucosa1256 and the midline septum 1255. Each end of the tissue retractor 1201can have a hooking mechanism. The hooking mechanism can be varied andmany variations are known in the art. Non-limiting examples of suitablehooking mechanisms on the tissue retractor 1201 are: hooks, barbs,helixes, staples, screws, sutures, biointegrated permanent material,collagen, and elastin. The hooking mechanism on each end of the tissueretractor 1201 can be the same as one another or can be different fromone another. The tissue retractor 1201 has an anchor member and aretractor member connected by a shaft. For example, in one embodiment,the anchor member is a staple and the retractor member is a hook.However, in one embodiment, the tissue retractor 1201 has a shortelastic shaft with a hook of firmer consistency at either end.

In one embodiment, a breathing disorder is treated with a tissueretractor 1201 in which a retractor member is connected at a first endof a shaft and an anchor member is connected at a second end of theshaft. The shaft is inserted into a patient's tongue 1251 between thesuperior layer 1258 and the middle layer 1254. One of the retractormember and the anchor member is attached to the mucosa tissue fascia,for example, to the connective tissue 1256. The other of the retractormember and the anchor member is attached to the midline septum 1255tissue fascia. At least one of the shaft, the retractor member, and theanchor member interact to exert a pressure that prevents a portion ofthe patient's tongue 1251 from obstructing the patient's oral cavity orpharynx. The tissue retractor 1201 prevents a portion of the patient'stongue 1251 from moving toward other soft tissue located in thepatient's oral cavity or pharynx. As a result, the airway is maintainedin the open position. In some embodiments, the pressure is acounterforce pressure. In other embodiments, the pressure is exerted onthe tongue base 1253. In some embodiments, the portion of the patient'stongue is the midline septum 1255 of the tongue 1251. The middle layer1254 of the tongue 1251 can include the midline septum 1255. In someembodiments, the tissue retractor 1201 (e.g., the retractor member, theshaft, and the anchor) are positioned on a needle, the needle isinserted to a desired depth within the patient's tongue 1251, the needleis removed, and the tissue retractor 1201 remains where inserted in thepatient's tongue 1251.

In alternative embodiments, the implanted tissue retractor 1201 (e.g.,an LTR) can vary in overall length from 1 mm to 3 cm in length.Alternatively, longer length tissue retractors 1201 (e.g., LTR's) cancouple the tongue base 1253 tissue to the boundary fascia 1261. Thetissue retractor 1201 can couple the tongue 1251 and genioglossus muscle1263, through the boundary layer 1261 to the genioglossus muscle 1263.The tissue retractors 1201 can couple the tongue 1251 to the floor ofthe patient's mouth or to the mandible. Coupling of the tissue retractor1201 to the patient's tissue can be accomplished via barbs, hooks,fibrotic reaction, or other methods known in the art. The tissueretractor 1201 implant can be composed of biodegradable material thatdecomposes in from about a week to about a year, for example. Manymaterials used for surgical sutures can be adapted for use in a tissueretractor 1201 to enable the material to be biodegraded or bioresorbedwhen implanted in the body of the patient.

Preferably the shaft of the tissue retractor 1201 is oriented such thatthe force on the retractor is at least one orientation that includesdownward, forward, and to the side. In one embodiment, the tissueretractor 1201 is oriented a combination of downward and forward.Multiple tissue retractor 1201 implants may be used along the midline ofthe tongue 1251 to distribute the coupling force without interferingwith normal function. Depending on the anatomy of the patient, tissueretractor 1201 implants may be inserted at any site in the tongue 1251.In one embodiment, the tissue retractor 1201 is implanted in the midlineseptum 1255 of the tongue 1251. In another embodiment, the tissueretractor 1201 is implanted in the midline of the tongue curve 1253. Oneor more of the following aspects of the tissue retractor 1201 can beused to mold the effects of the tissue retractor 1201 for the exactneeds of the individual patient: implant site and orientation, shaftlength and elasticity, and hook size, shape, and hardness.

The tissue retractor 1201 implant may be bioresorbable over a period offrom about 1 day to about 10 years, or from about 1 month to about 1year, or from about 1 month to about 6 months. Preferably, the timerange allows sufficient time for remodeling of the tongue 1251 in amanner that avoids breathing disorders such as snoring and sleep apnea,for example. In one embodiment, a the tissue retractor 1201 implant isbioresorbed, which is preferable to a tissue retractor 1201 implant thatis permanently left in the tongue, without bioresorption.

It is preferable that permanent or bioresorbable tissue retractor 1201implants be inserted into superficial levels of the tongue 1251 in areasnormally not undergoing a great amount of shape change during normaltongue 1251 activity. Such positioning minimizes the possibility thatthe tissue retractor 1201 implantation will impede normal function,particularly if there is an infection or fibrous reaction to theimplant. To plan for atraumatic removal of the implant in cases of, forexample, infection, pain or other complication, the tissue retractor1201 implant should be designed to be easily removed from the patient'stongue 1251 without extensive surgery. To facilitate removal of thetissue retractor 1201 implant, the tear strength of the ends of thetissue retractor 1201 (e.g., the tear strength of either the retractormember or the anchor member or both) should range from about 1 to about1000 grams. In one embodiment, the tear strength of hooking mechanismsat each end of a tissue retractor 1201 is about 500 grams. In anotherembodiment, the tear strength of the ends of the tissue retractor 1201should range from about 10 to about 100 grams. In one embodiment, wherethe ends of the tissue retractor 1201 has hooks with one or more arms atthe first end, then one or more of the arms of the hook fold straight ata tear strength limit, which allows the tissue retractor 1201 implant tobe removed from the patient's tongue 1251 without further damage totissue of the tongue 1251 as the tissue retractor 1201 is extracted.

In further embodiments, referring now to FIGS. 12A-12F, a method fortreatment of a breathing disorder employs a tissue retractor 1201, whichincludes a retractor member connected at or near a first end of a shaftand an anchor member connected at or near a second end of the shaft. Inaccordance with the method, a shaft is inserted into a patient's tongue1251 between the superior layer 1258 and the middle layer 1254. One ofthe retractor member and the anchor member is attached to the mucosatissue fascia. The other of the retractor member and the anchor memberis attached to the midline septum 1255 tissue fascia. At least one ofthe shaft, the retractor member and the anchor member interact to exerta counterforce pressure that prevents a portion of the patient's tongue1251 from obstructing the patient's oral cavity or pharynx. The methodcan also include positioning the tissue retractor 1201, namely theretractor member, the shaft, and the anchor member, on a needle andinserting the needle to a desired depth within the patient's tongue1251, and thereafter removing the needle to leave the tissue retractor1201 inserted in the patient's tongue 1251.

In some embodiments, the portion of the patient's tongue 1251 that isprevented from obstructing the patient's oral cavity or pharynx is thebase 1153 of the patient's tongue. In some embodiments, one or more ofthe shaft, the retractor member, and the anchor member is bioresorbable.After insertion of the tissue retractor 1201 into the patient's tongue1251 all or a portion of the tissue retractor 1201 is bioresorbed by thepatient's body. In some embodiments, the portion of the patient's tongue1251 is the midline of the tongue. The middle layer 1254 can be themidline septum 1255.

6. Tongue Base Retraction (FIG. 13)

Disclosed here are embodiments of the invention that focus on retractingtissue of the tongue base, particularly the tongue base mucosa. This hasthe advantage that it is easy to insert by the physician, minimallyinvasive and easily adjustable by the patient.

Referring now to FIGS. 13A-13D, in one embodiment, the tissue retractor1301 device is inserted from one site to another site and both sites areon the superior surface of the tongue 1351, which can include the tonguebase surface. The anterior part of the tissue retractor 1301 device isthe anchor member 1330 and the posterior part is the retractor member1320. In the tissue retractor, a shaft 1310 runs between the anchormember 1330 and the retractor member 1320. Tension between the retractormember 1320, the shaft 1310, and the anchor member 1330, retracts thetongue 1351 surface and displaces the tongue base. Although the countertraction of the tissue retractor 1301 affects the anterior tonguesurface, it has no effect on normal tongue 1351 function.

In one embodiment, referring to FIG. 13A, the shaft 1310 of the tissueretractor 1301 passes directly underneath the mucosa of the tongue 1351.In another embodiment, referring to FIG. 13B, the shaft 1310 takes amore direct line through the tongue 1351. Passing the shaft directlyunderneath mucosa of the tongue 1351 (see, FIG. 13A) is easier for thephysician than inserting it directly through the tongue 1351 (see, FIG.13B). In the configuration shown in FIG. 13A, the force at the retractormember 1320 (e.g., the retractor head) is oriented laterally, and thiscauses the mucosa posterior to the retractor member 1320 to be pulledtaut with some degree of indentation. In the more direct route insertedthrough the tongue 1351 and shown in FIG. 13B, the retraction force ofthe retractor member 1320 is oriented close to perpendicular to thetongue surface and there is more indentation then mucosal tension ascompared to the less direct route where the shaft 1310 passes directlyunderneath the mucosa of the tongue 1351. The exact orientation of thetissue retractor 1301 and the insertion path of the tissue retractor1301 can be varied to maximize the beneficial effects of the tissueretractor 1301 in the patient's tongue 1351.

Referring now to FIG. 13C, in another embodiment, the tissue retractor1301 shaft 1310 runs most of its course along the surface of the tongue1351. A portion of the shaft 1310 is disposed under the mucosa close tothe retractor member 1320 and is connected to the retractor member 1320,another portion of the shaft 1310 is disposed under the mucosa close tothe anchor member 1330 and is connected to the anchor member 1330, andthe remainder of the shaft 1310 is disposed along the external surfaceof the tongue 1351. This has the advantage of avoiding even theminimally invasive tunnels formed by FIGS. 13A and 13B. Furthermore theconfigurations disclosed in FIGS. 13A, 13B, and 13C, can be combined andthe shaft 1310 can travel the entire distance under the mucosa or canre-emerge one or more times (13. C).

In another embodiment, referring now to FIGS. 13D-13H, at least aportion of the anchor member 1330 and/or at least a portion of theretractor member 1320 can be embedded beneath mucosa on the soft tissue1350 and the shaft 1310 is, optionally, detachable. In one embodimentthe anchor member 1330 has a first portion and a second portion and/orthe retractor member 1320 has a first portion 1321 and a second portion1322. The first portion (e.g., of the anchor member and/or the retractormember 1321) has one diameter and the second portion (e.g., of theanchor member and/or the retractor member 1322) has another diameter.The first portion has a diameter that ranges from about 1 mm to about 20mm, from about 2 mm to about 10 mm, or from about 3 mm to about 7 mm.The second portion has a diameter that ranges from about 1 mm to about20 mm, from about 2 mm to about 10 mm, or from about 3 mm to about 7 mm.

In one embodiment, referring to FIGS. 13E-13H, the first portion 1321 isa silastic disc about 5 mm in diameter that is implanted under themucosa of the soft tissue 1350. The second portion 1322 has a 1 mmdiameter extension 1323 that comes out of the pocket of soft tissue 1350in which the first portion 1321 is implanted. The extension 1323 ends ina second portion 1322 which, in one embodiment, is a 2 mm disc. Theshaft 1310 reversibly couples to the extension 1323 between the firstportion 1321 and the second portion 1322. Preferably, shafts 1310 areelastomeric. In one embodiment, the shaft 1310 is a simple medical graderubber band. In another embodiment, the shaft 1310 is a 1×1 mm strip ofelastomeric material with expansion at either end to accommodate precutkeyholes for attachment (e.g., reversible attachment) to an externalportion of an implanted anchor member 1320 or retractor member 1330. Inone embodiment, the attachment holes have 2 mm or greater inner keyholesto allow the end of the stretched shaft 1310 to pass over the retractorsecond portion 1322 and/or the extension 1323 and 1 mm outer holes orclefts that slot into the extension 1323. In some embodiments, materialsof the tissue retractor are pigmented to match the color of the tonguemucosa 1350. Referring now to FIG. 13H, in a further embodiment, thepatient is allowed to depress the elevated extension 1323 and/or theretractor second portion 1322 so that it is flush with the mucosa,particularly when the tissue retractor is not in use. Suitablemechanisms known in the art may be used to allow reversible depressionof a button like device of the retractor member 1320.

In a further embodiment, referring to FIG. 13I, an anchor member 1330 iscomposed of an elastic sleeve or band 1370 slipped over the tongue 1351blade. The shaft 1310 may be an integral part of the band 1370 or,alternatively, the shaft 1310 is a separate attachable component. Theband 1370 may be made of biocompatible materials such as silicone orother biocompatible elastomers. The distal end of the shaft 1310 can bereversibly attached to a portion of the retractor member 1320. In oneembodiment, referring again to FIGS. 13E-13H, the shaft 1310 reversiblycouples to the extension 1323 between a first portion 1321 and thesecond portion 1322. In another embodiment, a portion of the shaft 1310reversibly attaches to the second portion 1322 of the retractor member1320.

Suitable mechanisms by which a portion of the shaft 1310 and the implant(e.g., the retractor member 1320) are coupled may include elastic bands,clips, magnets of opposite polarity, a first magnet and a material ofopposite polarity, and other mechanisms well known to those skilled inthe art. The advantages of this arrangement are that only a smallpartially embedded implant (e.g., retractor member 1320 having animplanted first portion 1321 and a second portion 1322) is needed toachieve retraction of the soft tissue 1350 (e.g., a portion of thetongue 1351).

Referring now to FIGS. 13A-131, a tissue retractor 1301 for treatment ofa breathing disorder has a retractor member 1320 with a first portion1321 sized for implantation into a soft tissue located in a patient'soral cavity or pharynx and a second portion 1322 sized for placementexternal to the soft tissue. A portion of a shaft 1310 (e.g., the firstend 1311 of the shaft 1310) contacts the second portion 1322 of theretractor member 1320 and another portion of the shaft 1310 connects ator near an anchor member 1330. At least one of the retractor member1320, the shaft 1310, and the anchor member 1330 interact to exert apressure that prevents deformation of at least a portion of the softtissue that prevents obstruction of the patient's airway. In oneembodiment, the shaft 1310 is external to the soft tissue. In someembodiments, a first end 1311 of the shaft 1310 connects at or near theanchor member 1330, a second end of the shaft 1310 connects at or near asecond anchor member 1330, and the portion of the shaft 1310 exerts thepressure on the second portion 1322 of the retractor member 1320. Insome embodiments, the anchor member 1330 is a first magnet, the firstend 1311 of the shaft 1310 comprises a second magnet that attracts tothe first magnet, the second anchor member 1330 comprises a thirdmagnet, and the second end of the shaft 1310 comprises a fourth magnetthat attracts to the third magnet.

In some embodiments, the second portion 1322 of the retractor member1320 has a low profile when not contacting the shaft 1310.

The anchor member 1330 can be a band 1370 surrounding at least a portionof the external diameter of a patient's tongue 1351. The anchor member1330 can be a stud (e.g., a tongue stud commonly used in tongue piercingtypically associated with non-medical and cosmetic applications) on theexternal surface of a patient's tongue 1351.

In some embodiments, a method for treatment of a breathing disorderincludes implanting a first portion 1321 of a retractor member 1320 intoa soft tissue located in a patient's oral cavity or pharynx with asecond portion 1322 of the retractor member exterior to the soft tissue.A first end 1311 of a shaft 1310 is connected to the retractor member1320 and an anchor member 1330 is connected to a second end of the shaft1310. At least one of the retractor member 1320, the shaft 1310, and theanchor member 1330 interact to exert a pressure that preventsdeformation of at least a portion of the soft tissue that preventsobstruction of the patient's airway. The shaft may be external to thesoft tissue. The second portion 1322 of the retractor member 1320 has alow profile when not connected to the first end 1311 of the shaft 1310.In some embodiments, the anchor member 1330 has a first portionimplanted in a soft tissue located in a patient's oral cavity or pharynxand an anchor member 1330 second portion external to the soft tissue. Insome embodiments, the anchor member 1330 is a band 1370 surrounding atleast a portion of the external diameter of a patient's tongue 1351. Inother embodiments, the anchor member 1330 is a stud on an externalsurface of the patient's tongue 1351. In one embodiment, at least aportion of the retractor member 1320 is positioned in the region of thepharyngoglossal fold.

In some embodiments, referring now to FIG. 13J, a first anchor member1330 is positioned in a first region of soft tissue located in apatient's oral cavity or pharynx and a second anchor member 1330 ispositioned in a second region of soft tissue. A first portion of aretractor member 1320 is inserted into a third region of soft tissuelocated in the patient's oral cavity or pharynx and a second portion ofthe retractor member 1320 is exterior to the third region of softtissue. A first end of a shaft 1310 is connected at or near the firstanchor member 1330 and a second end of the shaft 1310 is connected at ornear the second anchor member 1330. One or more of the first anchormember 1330, the second anchor member 1330, the retractor member 1320,and the shaft 1330 interact to exert a pressure that preventsdeformation of at least a portion of soft tissue to prevent obstructionof the patient's airway. In one embodiment, at least a portion of theshaft exerts a pressure on the retractor member that preventsdeformation of the third region of soft tissue. In one embodiment, thefirst anchor member 1330 is a first magnet, the first end of the shaft1310 is a second magnet that attracts to the first magnet, the secondanchor member 1330 is a third magnet, and the second end of the shaft1310 is a fourth magnet that attracts to the third magnet. Optionally,one of the above-described magnets is replaced with a material otherthan a magnet (e.g., a ferrous material) to which another magnet isattracted.

In some embodiments, referring still to FIG. 13J, an anchor member 1330is placed in each PGF 1357. The anchors 1330 are attachment points for ashaft 1310 (e.g., an elastic band) passing over the base of the tongue1351 the shaft 1310 serves to retract the base of the tongue 1351. Forexample, one method for breathing disorder treatment includespositioning a first anchor member 1330 in the region of the firstpharyngoglossal fold 1357, positioning a second anchor member 1330 inthe region of the second pharyngoglossal fold 1357, and connecting afirst end of a shaft 1310 at or near the first anchor member 1330 andconnecting a second end of the shaft 1310 at or near the second anchormember 1330. At least one of the first anchor member 1330, the secondanchor member 1330 and the shaft 1310 interact to distribute a force onat least a portion of a tongue 1351 that prevents obstruction of thepatient's airway. A force is applied to the portion of the tongue 1351the prevents the portion of the tongue 1351 from falling toward othertissues located in the oral cavity or pharynx. In this way, thepatient's airway is maintained in the open position.

In some embodiments, the first anchor member 1330 comprises a firstmagnet, the first end of the shaft 1310 comprises a second magnet thatattracts to the first magnet, the second anchor member 1330 comprises athird magnet, and the second end of the shaft 1310 comprises a fourthmagnet that attracts to the third magnet.

In one embodiment, a first portion of a retractor member 1320 isinserted into the tongue 1351, a second portion of the retractor member1320 is exterior to the tongue 1351, and at least a portion of the shaft1310 contacts the second portion of the retractor member 1320. At leastone of the first anchor member 1330, the second anchor member 1330, theretractor member 1320, and the shaft 1310 interact to distribute a forceon at least a portion of the tongue 1351 to prevent obstruction of thepatient's airway. In one embodiment, a portion of the shaft 1310 (e.g.,a first end of the shaft 1310) contacts, is coupled to, or presses upona smaller retractor member 1320 that is semi-implanted in the tongue1351 tissue. In one embodiment, at least a portion of the shaft 1310 isinternal to the tongue 1351.

Referring now to FIG. 13K, a first tissue retractor 1301 a (e.g., anLTR) is anchored beneath the tongue 1351 blade by a first anchor member1330 a, a first shaft 1310 a passes through the tongue blade to a firstretractor member 1320 a. The first retractor member 1320 a acts as amodified anchor member and provides a second anchor member 1330 b on thesuperior surface of the tongue 1351. A second shaft 1310 b passesposteriorly to a semi implanted second retractor member 1320 b. The semiimplanted second retractor member 1320 b has a first portion implantedin the tongue 1351 and a second portion exterior to the tongue 1351. Theuse of a first tissue retractor 1301 a allows adjustment of tension ofthe second tissue retractor 1301 b. For example, the anchor site of thefirst anchor member 1330 a located beneath the tongue blade 1352 can beadjusted such that the retraction force of the first retractor member1320 a is altered. In this way, adjustment of the first anchor member1330 a adjusts the second anchor member 1330 b. Thus, the force exertedby the second retractor member 1320 b by the second anchor member 1330 bis altered by adjusting the first anchor member 1330 a. Morespecifically, in one embodiment, the patient manipulates the secondtissue retractor 1301 b by twisting the first tissue retractor 1301 a topull slack from the shaft 1310 b and thereby increase the force exertedby the semi implanted second retractor member 1320 b.

Referring now to FIG. 13L, a tissue retractor 1301 includes a shaft 1310sized for insertion into a patient's tongue 1351, a retractor member1320 is connected at or near a first end of the shaft 1310 the retractormember 1320 is positioned at the external surface of the tongue 1351 andan anchor member 1330 is connected at or near a second end of the shaft1310. Referring also to FIG. 13M, a band 1370 is sized to surround atleast a portion of the external diameter of the tongue 1351 and the band1370 moves in the direction 1379 to exert a pressure on at least one ofa portion of the retractor member 1320 and a portion of the shaft 1310to prevent deformation of a portion of the tongue 1351 preventingdeformation of a portion of a tongue 1351 avoids obstruction of thepatient's airway. A force is applied to the portion of the tongue 1351the prevents the portion of the tongue 1351 from falling toward othertissues located in the oral cavity or pharynx. In this way, thepatient's airway is maintained in the open position. In someembodiments, the band 1370 is dimensioned to rotate and push at leastone of a portion of the retractor member 1320 and a portion of the shaft1310.

In one embodiment, the tissue retractor 1301 is a rigid shaft 1310 thatconnects an anchor member 1330 below the tongue blade 1352 to aretractor member 1320 above the tongue blade 1352. Referring now to FIG.13M, a sleeve (e.g., a band 1370) is reversibly placed over the tongueblade 1352. The tissue retractor 1301 shown in FIG. 13L is rotatedforward by the band 1370. More specifically, the retractor member 1320and/or a portion of the shaft 1310 are rotated forward by the band 1370when the band 1370 is reversibly placed over the tongue blade 1352. Therotation of the retractor member 1320, along with the rigid shaft 1310,displaces the tissue of the tongue base 1353 along the midline. In someembodiments, the band 1370 rotates in the band direction 1379 shown inFIG. 13M to displace the tissue of the tongue base 1353 such that thetissue of the tongue base 1353 does not fall toward the soft palate, thepharyngeal wall, and/or other tissues in the oral cavity or pharynx andthe patient's airway is maintained in the open position.

In some embodiments, referring to FIGS. 13L-13M, a method for treatmentof a breathing disorder includes inserting at least a portion of a shaft1310 into a patient's tongue 1351, connecting a retractor member 1320 ator near a first end of the shaft 1310 at an external surface of thetongue 1351, and connecting an anchor member 1330 at or near a secondend of the shaft 1351. The method for treatment includes surrounding atleast a portion of the external diameter of the tongue 1351 with a band1370 disposed adjacent the retractor member 1320 and moving the band1370 in, for example, the direction 1379 to exert a pressure on at leastone of a portion of the retractor member 1320 and at least a portion ofthe shaft 1310 to prevent deformation of at least a portion of thetongue 1351 that prevents obstruction of the patient's airway. In someembodiments, moving the band 1370 comprises rotating the band 1370 andpushing at least a portion of the retractor member 1320 and at least aportion of the shaft 1310 to displace at least a portion of the tongue1351 to prevent obstruction of the patient's airway. In this way atleast a portion of the tongue 1351 does not fall toward other tissues inthe oral cavity or pharynx (e.g., the soft palate and/or the pharyngealwall) and the patient's airway is maintained in the open position.

Referring still to FIGS. 13L-13M, the tissue retractor 1301 is a commontongue ring (e.g., the retractor member 1320 is the tongue stud thatsits on the top surface of the tongue 1351). And the band 1370 sitsadjacent the tongue stud and rotates the tongue ring (e.g., the tonguestud and a portion of the shaft of the tongue ring) to displace at leasta portion of the tongue 1351 to prevent obstruction of the patient'sairway. In some embodiments, the tissue retractor 1301 can be loaded,e.g., the band 1370 is placed adjacent to the tissue retractor 1301 whenavoiding obstruction of the patient's airway is desired (e.g., at a timewhen the patient plans to sleep).

In other embodiments, referring to FIGS. 13K-13L and to the previouslydescribed FIG. 9E, the retractor member 1320 (e.g., the tongue stud of acommon tongue ring) is connected to a palatal prosthesis, one or more ofthe patient's teeth, or other dental anchor by, for example, a rubberband or a suture. Alternatively or in addition, the anchor member 1330(e.g., the portion of a common tongue ring beneath the tongue) can beconnected to a modified anchor (e.g., a dental anchor or an anchor inthe frenulum area).

7. Pharyngoglossal Fold

Referring now to FIGS. 14A-14E, 15A-15F, and 16A-16F, disclosed here aremethods and devices for using the PGF as a retractor or anchor site inorder to beneficially effect the tongue, pharyngeal walls and/or softpalate. On both sides of the tongue thin folds of mucosa connect thetongue to the mandible. These are called the pharyngoglossal folds(PGF). Within these folds are the palatoglossal, superior constrictor,styloglossus and hyoglossus muscles, from superior to inferiorrespectively. The PGFs separate the oral cavity (anterior) from thepharynx (posterior). Anterior to this PGF attachment there is no lateralconnection of the tongue and it is freely mobile. One of the muscleswithin the PGF is the palatoglossus which courses superiorly to connectwith the soft palate, thereby forming what is seen in mouth as theanterior tonsillar pillar.

Unexpectedly, the PGF has been found to have several advantages as aretraction site that enlarges the pharyngeal airspace. The connectivetissue of the PGF is connected with the connective tissue of the tongue.Therefore, it has been unexpectedly found that traction on the PGF istransmitted to the base of tongue. Moreover, as the superior pharyngealconstrictor and palatoglossus muscles are attached to the PGF and inturn connect with the lateral pharyngeal walls and soft palate thesestructures, the superior pharyngeal constrictor and palatoglossusmuscles, can also be retracted (FIG. 14). In particular, a preferredsite within PGF is its superior end, at the superior end many of thesemuscles (e.g., the superior pharyngeal constrictor, palatoglossusmuscles, the lateral pharyngeal walls, and the soft palate) overlap asthey insert into the tongue. Therefore, retraction at one site expandsthe pharyngeal airway by simultaneously stiffening and/or retracting thetongue base, lateral pharyngeal walls and soft palate. This combinedeffect of an expanded pharyngeal airway has a beneficial effect on sleepdisordered breathing.

A further advantage of the PGF is that it is easily accessible to boththe physician and patient. The PGF is not normally seen duringexamination of the mouth as it is in a folded state and hidden by thetongue surface that sits above the PGF. However, the PGF can be easilypalpated by sliding a finger along the floor of the mouth next to themandible, at the level of the edge of the mandible a smooth verticalwall is reached which blocks entry into the pharynx, this smoothvertical wall is the PGF. To visualize the PGF the tongue can beretracted medially with a tongue blade.

A further advantage of the PGF is that the PGF does not have a lot ofsensory innervation. The area of the mouth around the PGF is highlysensitive. Specifically, the tonsillar pillars (discussed in greaterdetail in association with FIG. 17) and the tongue surface next to thePGF are particularly sensitive areas of the upper airway that can causereflex gagging. However, it has unexpectedly been found that touchingthe PGF itself causes little or no reflex gagging. Moreover, where thereis any sensation (e.g., even a small amount of sensation) caused bycontacting or touching the PGF, when a device is placed in the region ofthe PGF and contacts the PGF for a period of time any sensationdisappears within minutes of the device contacting the PGF.

A further advantage of the PGF is that it is thin and easy to punctureyet contains enough connective tissue to provide a firm interface withall or a portion of a tissue retractor (e.g., a retractor member, ashaft, and an anchor member). Anatomical studies by the inventor haveshown that the PGF has few neurovascular structures. The PGF has athickness that ranges from about 1 mm to about 3 mm. Thereforecontacting, piercing, or puncturing the PGF is generally safe and thereis little risk of damage to the PGF, due to the PGF thickness. Thetissue in the PGF has only a minor amount of blood vessels and nerves.

In some embodiments, a tissue retractor (e.g., an LTR) is used todisplace the PGF and/or tissue in the region of (e.g., neighboring) thePGF. In some embodiments, retraction of the PFG is in an anteriordirection such that anterior retraction of the PGF displaces the entirebase of the tongue anteriorly thereby increasing the patientsretroglossal and retropalatal airspace. FIG. 15A shows an obstructedairway and FIGS. 15B-15F show anterior retraction of the tongue base dueto PGF retraction. In some embodiments, inferior retraction of the PGFdisplaces the tongue base inferiorly thereby removing tissue volume fromthe retropalatal area, the narrowest part of the upper airway. Thusinferior retraction increases the retropalatal airspace, which isdesirable for treatment of breathing disorders such as, for example,sleep apnea. In another embodiment, lateral retraction of the PGF wouldstiffen and flatten the posterior surface region of the tongue base. Aflatter posterior surface region of the tongue base may improve theavailable airspace in the patient's upper airway and therefore bedesirable for breathing disorder treatment. Without being bound to anytheory, it is believed that one or more of anterior retraction, interiorretraction, and lateral retraction of the PGF are more effective forbreathing disorder treatment than are posterior retraction or medialretraction of the PGF.

Retraction of the PGF may be in a single direction or in multipledirections (e.g., retraction of the PGF may be unilateral or bilateral).For example, in one embodiment the PGF on one side of a patient's mouth(e.g., the first side) is subject to anterior retraction by a firsttissue retractor and the PGF on the other side of the patient's mouth(e.g., the second side) is subject to anterior retraction by a secondtissue retractor. Methods of PGF retraction could be acute, just duringan obstructive episode, or semi acute, while sleeping (e.g., overnight),or for extended durations. Extended durations of PGF retraction wouldlikely cause tissue remodeling that would cause the patient's tongue totend to remain in a more anterior position such that when the tissueretractor is removed from the PGF and no force is being applied to thePGF the tissue remodeled tongue remains positioned in a more anteriorposition than its location prior to being subject to PGF retraction.

FIGS. 15A-15F depict the PGF 1557 and embodiments of PGF 1557retraction. FIG. 15A shows the posterior collapse of the tongue 1551whereby the tongue base 1553 collapses toward the pharyngeal wall 1565and/or the soft palate 1566 to reduce size of the patient's airway. Somepatient's having breathing disorders including snoring and sleep apneasuffer from a reduction of available patient airway to airflow 1569 asdepicted by FIG. 15A. Airway airflow 1569 reduction caused by theposterior collapse of the tongue 1551 can actually obstruct a portion ofthe airway or can create the sensation to the patient that the reducedsize airway is obstructed to airflow 1569. In accordance with someembodiment's of breathing disorder treatment, devices and methods areemployed to improve the patient's airway in a manner that preventsobstruction (e.g., prevents actual obstruction and/or prevents an airwaysize reduction that produces the sensation in the patient that theairway is obstructed to airflow 1569).

Referring now to FIG. 15B, in one embodiment, a retractor member 1520 ispositioned at or near the PGF 1557 (i.e., the first PGF), a shaft 1510connects to the retractor member 1520 and passes across the frenulum1560 (i.e., on the external surface of the frenulum 1560) to attach to asimilarly positioned retractor member 1520 positioned at or near the PGFon the opposite side of the patient's oral cavity (i.e., the secondPGF). More specifically, in some embodiments, a retractor member 1520 isadjacent the PGF 1557 (i.e., the first PGF) and a portion of the shaft1510 is inserted into the PGF 1557, another portion of shaft 1510 passesacross the frenulum 1560, the shaft 1510 enters the other PGF (i.e., thesecond PGF) and another retractor member is adjacent the second PGF. Thetwo PGF's are moved in the retraction direction 1513. Movement of thetwo PGF's in the retraction direction 1513 opens up the patient's airwayto airflow 1569 by, for example, moving the tongue base 1553 in theretraction direction 1513 rather than toward the pharyngeal wall 1565and/or toward the soft palate 1566.

Referring now to FIG. 15C, a retractor member 1520 is about or in thePGF 1557 and a shaft 1510 passes through the tongue 1551 tissue toemerge and connect to a modified anchor 1531. The modified anchor 1531may be a dental appliance or a tooth, for example. In one embodiment theretractor member 1520 lays against the PGF 1557, a portion of the shaft1510 passes through the PGF and another portion of the shaft 1510 passesthrough the tongue 1551 to the modified anchor 1531 located adjacent thefrenulum and/or in the region of the mandible. Movement of the PGF 1557in the retraction direction 1513 opens up the patient's airway toairflow 1569 by, for example, moving the tongue base 1553 in theretraction direction 1513 rather than toward the pharyngeal wall 1565and/or toward the soft palate 1566.

Referring still to FIG. 15C an alternative embodiment is also depictedshowing that the retractor member 1520 in the PGF 1557 passes throughthe tongue 1551 tissue through the floor of the mouth to an externalanchor 1532 resting on the patient's skin 1590, e.g., against thepatient's chin. In one embodiment, the retractor member 1520 laysagainst the PGF 1557, a portion of the shaft 1510 passes through the PGF1557 and another portion of the shaft 1510 passes through the tongue1551 to the external anchor 1532 resting external to the oral cavity onthe patient's skin 1590. The tissue retractor 1501 opens up thepatient's airway to airflow 1569 by, for example, moving the tongue base1553 in the retraction direction 1513 rather than toward the pharyngealwall 1565 and/or toward the soft palate 1566.

In one embodiment, referring now to FIG. 15D, an implanted tissueretractor 1501 has a retractor member 1520 implanted within the PGF 1557(or in neighboring tongue 1551 tissue) and a shaft 1510 passes throughthe tongue 1551 and passes anteriorly and inferiorly to an implantedanchor in the tongue 1551, an implanted anchor in the genioglossusmuscle, and/or an implanted anchor in structures located in or at thefloor of mouth. The tissue retractor 1501 opens up the patient's airwayto airflow 1569 by moving the PGF 1557 in the retraction direction 1513,which moves the tongue base 1553 away from the pharyngeal wall 1565and/or the soft palate 1566.

Referring now to FIG. 15E, in one embodiment the retractor member 1520is implanted against the superior PGF 1557 a and the shaft 1510 passesinferiorly through or outside the PGF 1557 to an anchor member 1530 thatis implanted against the same PGF 1557 either on the same side or on theopposite side of the retractor member 1520. Referring still to FIG. 15E,the tissue retractor 1501 includes a retractor member 1520 in thesuperior PGF 1557 a, a shaft 1510 passing through or outside the PGF1557, and an anchor member 1530 in the inferior PGF 1557 b. This methodretracts the superior PGF 1557 a in an inferior direction, namely, inthe retraction direction 1513, which opens up and prevents obstructionof the patient's airway to airflow 1569. Retraction of the PGF 1557avoids soft tissue movement toward the pharyngeal wall 1565 and/or thesoft palate 1566.

In a further embodiment, referring now to FIG. 15F, the retractor member1520 sits against the PGF 1557, a portion of the shaft 1510 passesthrough the PGF 1557 and another portion of the shaft 1510 passesthrough the tongue 1551 medially and superiorly to an anchor member 1530on the superior surface of the tongue 1551. In some embodiments, theanchor member 1530 is the tongue stud of a common non-medical tonguepiercing and one end of the shaft couples to the anchor member 1530(i.e., the tongue stud). For example, in some embodiments, an end of theshaft 1510 contains a material that attracts to the tongue stud such as,for example, a magnet that attracts to the tongue stud. In otherembodiments, an end of the shaft 1510 has a hook or a loop that coupleswith all or a portion of the anchor member 1530 (e.g., a tongue stud).This movement of the PGF 1557 by the tissue retractor avoids movement ofthe tongue base 1553 toward the pharyngeal wall 1565 and/or the softpalate 1566. In this way, the airway airflow 1569 is maintained open andfree from obstruction (or the sensation of obstruction).

In some embodiments, referring to FIG. 16A, a retractor member 1620 isdisposed in the tongue base 1653. An anchor member 1630 is disposed ineach PGF 1657. For example, in one embodiment, an anchor member 1630 isdisposed in the anterior (i.e., the front) of each PGF 1657. A shaft1610 connects each anchor member 1630 to the retractor member 1620 suchthat a first shaft 1610 is disposed between the anchor member 1630disposed in the first PGF 1657 and the retractor member 1620 and asecond shaft 1610 is disposed between the anchor member 1630 disposed inthe second PGF and the retractor member 1620. The first shaft 1610 andthe second shaft 1510 may be inside the tongue 1651, i.e., they may besub-mucosal. In some embodiments, there is a single shaft 1610 with afirst end connected to the first anchor member 1630, a second endconnected to the second anchor member 1630, and a portion of the shaft1610 contacts the retractor member 1620. The single shaft 1610 may besub-mucosal or, alternatively, it may be on the exterior surface of thetongue 1651. In another embodiment, the retractor member 1620 isimplanted at the tongue base 1653 and connects to two shafts 1610, oneshaft 1610 is placed at the first PGF 1657 and the other shaft 1610 isplaced at the second PGF 1657.

In some embodiments, referring to FIG. 16B, an anchor member 1630 isdisposed in each PGF 1657. For example, in one embodiment, an anchormember 1630 is disposed in the anterior (i.e., the front) of each PGF1657. A single shaft 1610 connects to each anchor member 1630 such thata first end of the shaft 1610 connects to an anchor member 1630 disposedin the first PGF 1657 and the second end of the shaft 1610 connects toan anchor member 1630 disposed in the second PGF 1657. At least aportion of the shaft 1610 is disposed substantially adjacent the base1653 of the tongue 1651 and the shaft 1610 can be exterior to the tongue1651. Alternatively, all or a portion of the shaft 1610 may be insidethe tongue 1651, i.e., it may be sub-mucosal.

In some embodiments, referring now to FIG. 16C, an anchor member 1630 isimplanted in or near each PGF 1657. A single shaft 1610 connects to eachanchor member 1630 such that a first end of the shaft 1610 connects toan anchor member 1630 disposed in or near the first PGF 1657 and thesecond end of the shaft 1610 connects to an anchor member 1630 disposedin or near the second PGF 1657. At least a portion of the shaft 1610 isdisposed substantially adjacent the base 1653 of the tongue 1651 and theshaft 1610 can be exterior to the tongue 1651. Alternatively, all or aportion of the shaft 1610 may be inside the tongue 1651, i.e., it may besub-mucosal. In one embodiment, the two anchor members 1630 are eachanterior to the two PGF's 1657.

In a further embodiment, referring now to FIG. 16D, an anchor member1630 is implanted in or near each PGF 1657 and each anchor member 1630is a magnet 1691 or other nonferrous material. A single shaft 1610connects to each anchor member 1630 such that a first end of the shaft1610 connects to an anchor member 1630 disposed in or near the first PGF1657 and the second end of the shaft 1610 connects to an anchor member1630 disposed in or near the second PGF 1657. In one embodiment each endof the shaft 1610 includes a magnet or other material that has apolarity opposite to the polarity of the anchor member 1630 implanted ator near the PGF's. At least a portion of the shaft 1610 is disposedsubstantially adjacent the base 1653 of the tongue 1651 and the shaft1610 can be exterior to the tongue 1651. Alternatively, all or a portionof the shaft 1610 may be inside the tongue 1651, i.e., it may besub-mucosal. In one embodiment, the two anchor members 1630 are eachanterior to the two PGF's 1657. In some embodiments, external structureshaving a polarity opposite the implanted anchor members 1630 (e.g., themagnets 1691) are employed to bond the implanted anchor member 1630s tothe external structures. For example, a dental appliance or insert suchas a mouth guard can contain a region that attracts to the implantedanchor members 1630 and that moves the PGF 1657 or the region of the PGF1657 in a desired direction. Such methods move the PGF 1657 in theretraction direction 1613, which opens up and prevents obstruction ofthe patient's airway. A patient can use the dental appliance at night toalleviate symptoms associated with breathing disorders including, forexample, sleep apnea.

Referring now to FIG. 16E (two figures on the left), in someembodiments, a retractor member 1620 can be implanted in the PGF 1657.The retractor member 1620 can be a magnet 1691 implanted in a PGF 1657that is retracted by a magnet 1691 or other material of oppositepolarity. The magnet 1691 of opposite polarity can be attached to amodified anchor, for example. A variety of coupling mechanisms could beused to retain the retractor member 1620 magnet 1691 within the PGF1657.

Referring now to FIG. 16E (two figures on the right) a retractor member1620 can be an implanted magnet 1691 enclosed that has two flanges tokeep the magnet 1691 in place within the PGF 1657. For example, theretractor member 1620 can have a flange surface near its posterioraspect that would provide the interface against the PGF 1657 to causeanterior retraction of the PGF 1657. The flange surface can have a rimthat forms an edge around a portion of the PGF 1657 that is beingretracted.

In another embodiment, the retractor member 1620 has a first flange withan exterior edge and an interior shaft, the interior shaft can have afirst conduit. The second flange can likewise have an exterior edge andan interior shaft having a second conduit. When the retractor member1620 is implanted in the PGF 1657 the first flange is adjacent theposterior aspect and the interior shaft pierces the PGF to provide afirst conduit that flows through the PGF 1657 the second flange interiorshaft mates with first flange interior shaft and the second flange isadjacent the anterior aspect. Thus the first conduit and the secondconduit of the retractor member 1620 cut through the PGF 1657 andprovide a single conduit through the PGF 1657.

Referring to FIG. 16E (the two figures on the left and the two figureson the right) where magnets 1691 are implanted within each PGF 1657external modified anchors with magnets or other materials of oppositepolarity may be used to bond to the implanted magnets 1691 and to anchorthem to external structures. Suitable external modified anchors caninclude, for example, a dental appliance or insert such as a mouth guardthat has a region that attracts to the implanted magnets 1691. Thisembodiment is minimally invasive and allows the patient a very highdegree of comfort during the day when the implant is unconnected andtherefore unloaded (e.g., when the modified anchor is not inserted inthe patient's mouth). Suitable modified anchors can include variousshaft and anchor combinations. A variety of external modified anchorscan be tested without needing to replace the retractor member implant(e.g., the magnet 1691).

In some embodiments, a tissue retractor 1601 is employed in the regionof the PGF 1657 such that the anchor member 1630 of the tissue retractor1601 is coupled to a dental anchor (e.g., the anchor member 1630 iscoupled to the patient's tooth 1698 or other dental structure in thepatient's mouth). The anchor member 1630 could be a full loop, a partialloop, or a hook that anchors to the tooth 1698 or to a palatalprosthesis. The tissue retractor 1601 retractor member 1620 couples tothe PGF 1657 using magnets or other mechanical mechanisms known in theart. In some embodiments, the dental anchor is employed to retract thePGF 1657. An advantage of this device is that the PGF 1657 is very closeto the mandibular teeth and a secure but reversible loading of theimplanted tissue retractor 1601 between the PGF 1657 and the teeth 1698can therefore be achieved with short devices. Moreover, due in part tothe relatively short route from the PGF 1657 to the molar teeth 1698 thetissue retractor 1601 is unlikely to cause the patient significantdiscomfort.

FIG. 16F (on the left) shows a schematic of a tissue retractor 1601having an anchor member 1630 that aligns with a dental type modifiedanchor. The anchor member 1630 reversibly attaches to teeth 1698 asshown on right. A shaft 1610 of variable length attaches to a retractormember 1620 (e.g., a coupling mechanism) that in turn connects to animplant in the mouth. The implant can be a magnet that is positioned ator near the PGF 1657. For example, the retractor member 1620 may be amagnet or a mechanical mechanism. FIG. 16F (on the right) depicts adrawing of a tongue and a mandible as seen from above.

FIG. 16F (on the right) shows a tissue retractor 1601 a having a magnetimplanted at or near the PGF 1657 the implanted magnet is attracted toan end of the shaft 1610 that is coupled to a retractor member 1630 thatsurrounds the patient's tooth 1698. In one embodiment, the end of theshaft 1610 has a magnet that is attracted to the magnet implanted at ornear the PGF 1657. FIG. 16F (on the right) also shows the tissueretractor 1601 b that acts to mechanically hook the PGF 1657, which isdescribed in greater detail in FIG. 21H in association with the tissueretractor 2101. Referring now to FIGS. 16A-16F forces on the retractormember 1620, anchor member 1630, and/or shaft 1610 improve the patient'sairway in a manner that prevents obstruction (e.g., prevents actualobstruction and/or prevents an airway size reduction that produces thesensation in the patient that the airway is obstructed to airflow). Insome embodiments, the PGF 1657 is moved in a direction that opens up thepatient's airway and prevents obstruction of the patient's airway toairflow. In some embodiments, soft tissue movement toward the pharyngealwall and/or the soft palate is avoided. In other embodiments, the tonguebase 1653 is moved in a direction away from the pharyngeal wall and/orthe soft palate.

All of a portion of the tissue retractors described herein may becoupled to structures such as, for example, the PGF, the area lateral tothe PGF, the styloglossus, hyoglossus, chondroglossus, pharyngealconstrictor, levator and tensor of the palate, masetter, temporalis,pterygoid, facial, and platysma muscles; the hyoid, mandible, facial,and vertebral bones; the thyroid, cricoid, epiglottic cartilages; thestylohyoid, ptyrogomandibular ligaments, and other fascial structures.

8. Soft Palate and Tonsillar Folds

Disclosed here are methods and devices for retracting the lateralpharyngeal walls and soft palate. FIGS. 17A-17C show the basic anatomyof the internal soft palate structures and some embodiments employingtissue retractors to retract portions of the soft palate. The softpalate is a thin muscular structure that separates the nasopharynx andvelopharynx from the oral cavity. It begins at the edge of the hardpalate and extends downward toward the throat. In the midline it ends atthe uvula, and on each side it divides into two folds that surround thepalatine tonsils: the anterior tonsillar fold, also called thepalatoglossal fold, inserts into the side of the tongue near thesuperior PGF; the posterior tonsillar fold, also called thepalatopharyngeal fold, inserts into the lateral pharyngeal wall.

Excess length or thickness of the soft palate decrease the volume of thevelopharynx and contribute to snoring and sleep apnea. In addition,laxity of the soft palate and laxity of the pharyngeal walls predisposesa patient's airway to airway collapse. Tissue retractors and methodsemploying tissue retractors can reversibly or persistently thin,stiffen, and/or retract the soft palate and pharyngeal wall structure toavoid obstruction of the patient's airway.

Tissue retractors can be employed in a portion of the soft palate in amanner similar to tissue retractor placement in the tongue or the PGF,for example. In accordance with one tissue retraction method, an anchormember is disposed external the PGF, a shaft is disposed through the PGFand through the soft palate, and the retractor is on an external surfaceof the soft palate. Specifically, a tissue retractor placed in the softpalate could rest in place unloaded with a minimum tension (e.g., fromabout 1 gm to about 100 gm, or from about 5 gm to about 15 gm) that issufficient to keep the shaft within the soft palate tissue with theanchor member and/or retractor member resting against the mucosa (e.g.,against the external surface of the soft palate). The patient wouldtherefore have little or no sensation of the presence of the tissueretractor. During the time for sleep (e.g., at night) the tissueretractor could be “loaded” (e.g., the tension exerted on the tissueretractor could be increased to from about 1 gm to about 1000 gm, orfrom about 5 gm to about 100 gm). In some embodiments, the tissueretractor is loaded by placing a modified anchor (e.g., a bolster)between the anchor and the mucosa. In other embodiments, the tissueretractor is loaded when it is connected to a dental anchor (e.g., adental device like a retainer or mouth guard, a tooth, or a dentalimplant). The exact site and orientation of the lateral tissue retractorhas a great influence on whether the effects of the tissue retractor areprimarily to compress or to displace tissue.

FIGS. 17A-17C show different views of four exemplary tissue retractorpositions where each of the four tissue retractors has an anchor member1730 positioned in the same anchor site, at the superior PGF. Theremaining portions of each of the four tissue retractors (i.e., theshaft and retractor member) has a different placement position and eachof the four tissue retractor has a different beneficial effect.Generally, at least a portion of the shaft is disposed inside the tissueof the soft palate.

FIG. 17A is a view of the mouth showing the soft palate andpalatoglossal folds. FIG. 17B is the same view as FIG. 17A, but withmucosa removed showing the underlying muscles (right side) and the nerveand blood supply (left side). FIG. 17C show the view of the left lateralpharyngeal wall area after mid-sagittal section of FIG. 17B and thetongue is retracted inferiorly. Four positions for placement of tissueretractors are shown, in each of the four positions an anchor member1730 is positioned in the superior PGF. In position 1 the shaft passesnext to palatoglossus muscle around the tonsil, the retractor restagainst lateral edge of soft palate. This embodiment increases thelateral velopharyngeal area. Position 1 is oriented to achieve inferiordisplacement of the lateral aspect of the soft palate, thereby enlargingthe velopharynx.

In position 2 the shaft travels within the palatoglossus muscle, theretractor is near the midline soft palate. This embodiment increasesmedial velopharyngeal airspace. In position the tissue retractor passesto the midline of the soft palate. The exact location, force and numberof tissue retractors can be varied in order to best treat the specificpathology of each patient

In position 3 the shaft passes through the palatoglossus muscle, thepalatine tonsil, and the palatopharyngeus muscle, the retractor restsagainst the posterior wall of the soft palate. This embodimentcompresses and permanently remodels the palatine tonsil. In position 3the tissue retractor passes across the tonsil to a retractor on thepharyngeal side of the posterior tonsillar pillar. The tonsils in sleepapnea patients often are enlarged relative to the tonsils in individualswho do not suffer from sleep apnea and this enlargement contributes tothe excess soft tissue of the upper airway. Tension in the shaft wouldcompress and the tonsils and decrease their volume.

In position 4 the shaft passes 1 cm under the tongue base mucosa and theretractor rests against tongue base. This position of tissue retractorplacement can be employed for tensing the tongue base. In position 4 thetissue retractor passes from the superior PGF to the mucosa of thetongue base. This embodiment stiffens the mucosa of the tongue base andprevents the tongue base from deforming backward.

Referring now to FIGS. 15-17, a method for treatment of a breathingdisorder includes positioning a shaft having a first end and a secondend in a patient's oral cavity or pharynx and connecting one of aretractor member and an anchor member at or near the first end and inthe region of the pharyngoglossal fold. The other of the retractormember and the anchor member is connected at or near the second end ofthe shaft. At least one of the shaft, the retractor member, and theanchor member interact to distribute a force on at least one of a tonguebase, a lateral paryngeal wall, a tonsillar fold, or a soft palate andthe force prevents obstruction of the patient's airway. Optionally atleast a portion of the retractor member or at least a portion of theanchor member is positioned: on an external surface of thepharyngoglossal fold or behind the pharyngoglossal fold. In oneembodiment, at least a portion of the retractor member or at least aportion of the anchor member is disposed inside the region of thepharyngoglossal fold. In some embodiments, the first end of the shaftcomprises a first magnet and one of the retractor member and the anchormember comprises a second magnet or a ferrous material that attracts tothe first magnet. In some embodiments, the retractor member is in theregion of the pharyngoglossal fold and the anchor member couples to atooth. In some embodiments, at least a portion of the shaft is internalto at least one of the pharyngoglossal fold and a tongue. Optionally, atleast a portion of the anchor member or at least a portion of theretractor member is positioned inside the patient's mouth, in the regionof the patient's frenulum, external to the patient's mouth, adjacent asurface of a tongue, inside a tongue, or external to a soft palate.

Referring still to FIGS. 15-17, a tissue retractor for treatment of abreathing disorder can include a retractor member having a first magnet,a shaft sized for placement in a patient's oral cavity or pharynx with afirst end of the shaft having a second magnet or other material thatattracts to the first magnet, and an anchor member connected at or nearthe second end of the shaft. At least one of the shaft, the retractormember and the anchor member interact to distribute a force on a softtissue in the patient's oral cavity or pharynx, and the force preventsobstruction of the patient's airway. The anchor member can couple to atooth, for example, the anchor member can surround at least a portion ofthe tooth.

FIGS. 18A-18F show a variety of methods for treatment of a breathingdisorder employing a tissue retractor 1801 in the tonsillar folds.Referring to FIG. 18A, a tissue retractor 1801 includes a retractormember 1820 connected to a first end of a shaft 1810 and an anchormember 1830 connected to a second end of the shaft 1810. The retractormember 1820 is on the posterior surface of posterior tonsillar fold, atleast a portion of the shaft 1810 is inside the tissue of the softpalate, and the anchor member 1830 is positioned on the anterior surfaceof anterior tonsillar fold. The tissue retractor 1801 placement shown inFIG. 18A compresses the palatine tonsil. Referring now to FIG. 18B, theretractor member 1820 is in the superior Palatoglossus fold an anchormember 1830 is in the inferior Palatoglossus Fold or PGF. A shaft 1810connects the retractor member 1820 to the anchor member 1830.

Referring now to FIG. 18C, the tissue retractor 1801 is implanted withinthe palatoglossus muscle, this fully implanted tissue retractor 1801including an anchor member and a retractor member connected by a shaftis implanted in non tongue tissue for treatment of breathing disorders.In one embodiment, the inferior end of the tissue retractor 1801 is theanchor member and the superior end of the tissue retractor 1801 is theretractor member. Referring now to FIG. 18D, the anchor member 1830 ispositioned at the lateral portion of the soft palate, at least a portionof the shaft 1810 is positioned inside the tissue of the soft palate,and the retractor member 1820 is positioned at the midline of the softpalate. Referring now to FIG. 18E, the tissue retractor 1801 has aretractor member 1820 on the inner surface of the palatoglossal fold andthe tissue retractors anchor member 1830 is a modified dental anchorthat couples to a patient's tooth 1898. In one embodiment, the anchormember 1830 surrounds a portion of the patient's tooth 1898. Forexample, the anchor member 1830 can have the shape of a hook thatsurrounds only a portion of the patient's tooth 1898. All or a portionof the shaft 1810 may be inside the soft palate tissue. Alternatively,both the shaft 1810 and the anchor member 1830 are external to the softpalate tissue. Referring now to FIG. 18F, the tissue retractor 1801 hasa retractor member 1820 that is located posterior to the tonsillar fold,at least a portion of the shaft 1810 is inside the tissue of the softpalate, and the anchor member 1830 is anterior the tonsillar fold. Thetongue, the lateral pharyngeal walls, and the soft palate can alone orin combination contribute to obstructions related to breathing disorderssuch as sleep apnea. More specifically, the lateral pharyngeal walls andthe soft palate contribute extra soft tissue that decreases the volumeof the velopharyngeal airspace. In patients that suffer from breathingdisorders such as obstructive sleep apnea the lateral pharyngeal wallsand the soft palate can become flaccid. Suitable tissue retractors canbe employed to retract and/or tighten the soft tissue in the lateralpharyngeal walls and the soft palate thereby enabling patentcy of thepatient's airway. In some embodiments, all or a portion of the patient'stonsils are compressed, thereby directly decreasing the volume of thepatients tissue by, for example, tissue remodeling.

Referring now to FIGS. 18A-18F, a method for treatment of a breathingdisorder includes implanting into a tonsillar fold in a patient's oralcavity or pharynx a shaft 1810 with a retractor member 1820 connected ata first end and an anchor member 1830 connected at a second end. Atleast one of the shaft 1810, the retractor member 1820, and the anchormember 1830 interact to distribute a force on a soft tissue in thepatient's oral cavity or pharynx. The force exerted on the soft tissueprevents obstruction of the patient's airway.

Referring still to FIGS. 18A-18F, a method for treatment of a breathingdisorder includes implanting at least a portion of a shaft 1810 having afirst end and a second end into a tonsillar fold in a patient's oralcavity or pharynx. One of a retractor member 1820 and an anchor member1830 is connected at or near the first end of the shaft 1810 and theother of the retractor member 1820 and the anchor member 1830 areconnected at or near the second end of the shaft 1810. At least one ofthe retractor member 1820 and the anchor member 1830 is external to thetonsillar fold and at least one of the shaft 1810, the retractor member1820, and the anchor member 1830 interact to distribute a force thatprevents obstruction of the patient's airway. In one embodiment, theforce pushes at least a portion of the soft palate to open at least aportion of the patient's airway. In some embodiments, the anchor member1830 surrounds at least a portion of the patient's tooth 1898. In someembodiments, the anchor member 1830 is external to an anterior tonsillarfold.

FIGS. 19A-19F show embodiments for treatment of a breathing disorder inwhich a tissue retractor 1901 is disposed in a patient's soft palate1966. FIG. 19A shows an embodiment of a midline tissue retractor 1901disposed in the soft palate 1966 with an anchor member 1930 disposed onthe pharyngeal side 19661 near the hard palate. The shaft 1910 passesthrough soft tissue of the soft palate 1966, and the retractor member1920 head is in the uvular area (FIG. 18D). The retractor member 1920 isdisposed on the oral side 19662 of the soft palate 1966. In oneembodiment, the anchor member 1930 is disposed on the superiorpharyngeal side 19661 and the retractor member 1920 is on the inferiororal side 19662. The retractor member 1920 can be inserted so that itfaces any of the forward, downward or backward direction. The anchormember 1920 can rest against the mucosa on the pharyngeal side 19661.The anchor member 1930 can be available to couple to a modified anchoron the pharyngeal side 19661 of the soft palate 1966. The modifiedanchor can be, for example, an implant disposed in the pharyngeal wall.

FIG. 19B shows a tissue retractor 1901 disposed in the soft palate 1966with an anchor member 1930 disposed on the inferior pharyngeal side19661, the shaft 1910 passes through soft tissue of the soft palate1966, and the retractor member 1920 is disposed on the superior oralside 19662 of the soft palate 1966. The retractor member 1920 could beinserted so it faces either forward, downward or backward. Optionally,the anchor member 1930 could rest against the mucosa on either the oralside 19662 or the pharyngeal side 19661. The anchor member 1930 would beavailable to couple to a modified anchor such as a dental appliance onthe oral side 19662 or a modified anchor on the pharyngeal side 19661.

FIG. 19C shows the effect of a modified anchor on the shape and positionof the soft palate 1966. The modified anchor can be used in conjunctionwith a tissue retractor 1901. In one embodiment, the modified anchor isa bolster 1940. The tissue retractor 1901 is disposed in a patient'ssoft palate 1966 such that a shaft 1910 passes through the soft tissueof the soft palate 1966, the retractor member 1920 is connected at ornear a first end of the shaft 1910 and the anchor member 1930 isconnected at or near a second end of the shaft 1910. At least one of theanchor member 1930 and the retractor member 1920 is disposed on anexternal surface of the soft palate 1966. The bolster 1940 is, in oneembodiment, disposed between the external surface of the patient's softpalate 1966 and the anchor member 1930. In one embodiment, the bolster1940 has a recess in its surface that is designed to allow the anchormember 1930 head to fit into the bolster 1940 recess, such that afterinsertion the combined anchor member 1930 and bolster 1940 presents asmooth and soft continuous surface. The surface of the combinationbolster 1940 and anchor member 1930 avoids effect on speech and/orswallowing and causes minimal discomfort to the patient. The bolster1940 rotates, stiffens, and indents the soft palate 1966 all of whichserves to decrease the patient's susceptibility to snoring and airwayobstruction. The amount of tension added by the bolster 1940 ranges fromabout 1 gm to about 500 gms, from about 5 gms to about 250 gms, or fromabout 10 gms to about 50 gms. Additional of the bolster 1940 to thetissue retractor 1901 can, in one embodiment, “load” the tissueretractor 1901 so that the “loaded” tissue retractor 1901 preventsobstruction of the patient's airway.

FIG. 19D shows another embodiment of a tissue retractor 1901 disposed inthe patient's soft palate 1966. The tissue retractor 1901 is implantedin the patient's soft palate 1966. The tissue retractor 1901 includes ashaft with a retractor member connected at or near a first end and ananchor member connected at or near a second end. In one embodiment ofthe implanted tissue retractor 1901 the anchor member is superior to theretractor member. In another embodiment of the implanted tissueretractor 1901, the retractor member is superior to the anchor member.

FIG. 19E shows an embodiment of a tissue retractor 1901 where the anchormember and the retractor member are both disposed on the externalsurface of the soft palate 1966 and each of the anchor member and theretractor member are aligned on either side of the soft palate 1966(i.e., the retractor member opposes the anchor member and the shaft isdisposed through the soft tissue of the soft palate 1966). In oneembodiment, the aligned anchor member and retractor member of the tissueretractor 1901 are employed to compress a thickened soft palate 1966.Each of the anchor member and the retractor member of the tissueretractor 1901 provide tension along the tissue retractor 1901 shaftthat compresses and thins the soft palate 1966 tissue that lies betweenthe anchor member and the retractor member.

FIG. 19F, shows an embodiment of a tissue retractor 1901 where theanchor member and the retractor member are both disposed on the externalsurface of the soft palate 1966 and each of the anchor member and theretractor member are aligned on either side of the soft palate 1966(i.e., the retractor member opposes the anchor member and the shaft isdisposed through the soft tissue of the soft palate 1966). One or moreband 1970 is adjacent the external surface of the soft palate 1966, forexample, the band(s) 1970 are adjacent the edge of the soft palate 1966with a first end of the band 1970 substantially adjacent the anchormember and a second end of the band 1970 substantially adjacent theretractor member of the tissue retractor 1901. For example, in oneembodiment, the first end of the band 1970 is disposed between theanchor member and the external surface of the soft palate 1966,optionally, a portion of the shaft external to the soft tissue is placedthrough an aperture disposed in the first end of the band 1970.Likewise, the second end of the band 1970 is disposed between theretractor member and the external surface of the soft palate 1966 andanother portion of the shaft external to the soft tissue is placedthrough an aperture disposed in the second end of the band 1970.Alternatively, each end of the band 1970 is held between the anchormember and the soft tissue and the retractor member and the soft tissueby compressive force.

Referring to FIGS. 19A-19F, a method for treatment of a breathingdisorder includes inserting a shaft 1910 into a soft palate 1966 locatedin a patient's oral cavity or pharynx, connecting a retractor member1920 at or near a first end of the shaft 1910, and connecting an anchormember 1930 at or near a second end of the shaft 1910. At least one ofthe shaft 1910, the retractor member 1920, and the anchor member 1930interact to exert a pressure that prevents deformation of a portion ofthe soft palate 1966 to prevent obstruction of the patient's airway. Inone embodiment, at least one of the retractor member 1920 or the anchormember 1930 is on an external surface of the soft palate 1966. In someembodiments, the method employs a band 1970, a first end of the bandconnects at or near the retractor member 1920, a second end of the band1970 connects at or near the anchor member 1930, and the band 1970externally surrounds at least a portion of the soft palate 1966. Atleast one of the shaft 1910, the retractor member 1920, the anchormember 1930, and the band 1970 interact to exert a pressure thatprevents deformation of a portion of the soft palate 1966 to preventobstruction of the patient's airway. The pressure that preventsdeformation of a portion of the soft palate 1966 avoids the tissue ofthe soft palate from moving toward regions of soft tissue within thepatient's oral cavity or pharynx, for example, a portion of the tissueof the soft palate 1966 does not move toward the patient's tongue. Theportion of the soft palate 1966 is retrained from being displaced anddeformed to restrict and/or close the patient's airway. Optionally, themethod includes disposing a bolster 1940 on an external surface of thesoft palate 1966 between the external surface of the soft palate 1966and one of the retractor member 1920 and the anchor member 1930.

Referring still to FIGS. 19A-19F, a tissue retractor 1901 for treatmentof at least one of snoring and sleep apnea includes a shaft 1910 sizedfor insertion into a patient's soft tissue, a retractor member 1920connected at or near a first end of the shaft 1910, the retractor member1920 positioned on an external surface of the patient's soft tissue, ananchor member 1930 connected at or near a second end of the shaft 1910,and a band 1970. The band 1970 is sized to surround at least a portionof the external diameter of the patient's soft tissue, a first end ofthe band 1970 is connected at or near the retractor member 1920, and asecond end of the band 1970 is connected at or near the anchor member1930. At least one of the shaft 1910, the retractor member 1920, theanchor member 1930, and the band 1970 interact to exert a pressure thatprevents deformation of a portion of the soft tissue to preventobstruction of the patient's airway. In one embodiment of the tissueretractor 1901, the anchor member 1930 is positioned on an externalsurface of the patient's soft tissue.

9. Veterinarian Embodiments

Referring now to FIGS. 20A-20G disclosed here are methods and devices totreat sleep apnea and related disorders in mammals such as, for example,horses. A non-limiting example of an non-human upper airway disorder isdorsal displacement of the soft palate (DDSP) in horses. Race horses aresuperb animal athletes that place the greatest demands on respiration.All non-human mammals have a different configuration of their upperairways. FIG. 20A shows the normal configuration of the horse upperairway during exercise. The soft palate 2066 overlaps and interlocks theepiglottis 2063 of the larynx to provide an open conduit for airflow2069 in the pharynx air space. Referring still to FIG. 20A, specificallythe soft palate 2066 and larynx are much closer and they usuallyinterlock. Specifically, the soft palate 2066 is firmly held around theepiglottis 2063 of the larynx so that the airway flow from the nosethrough the posterior pharyngeal wall 2071 and into the lungs isprotected and secure. In race horses this is of special importancebecause of the tremendous volume of air that must smoothly flow into andout of the lungs with each breath during exercise.

Referring now to FIG. 20B, in some horses this interlocking of the softpalate 2066 and epiglottis 2063 breaks down and the soft palate 2066passes backward over the epiglottis 2063. In DDSP the soft palate 2066is dislodged from its locked position and obstructs the airway toairflow 2069. This displacement of the soft palate 2066 immediatelyinterferes with breathing and then the animal stops running. Althoughthe cause of DDSP is not known with certainty, many trainers believethat the tongue 2051 causes the displacement by moving backward andpushing the soft palate 2066 out of position. The displacement isbelieved to be caused by the backward movement of the tongue base 2053.For this reason many trainers actually tie the race horse's tongue 2051forward prior to the race, a solution that is crude and uncomfortablefor the animal.

Methods and devices are employed to prevent DDSP both by preventingbackward displacement of the tongue 2051 and by securely coupling thesoft palate 2066 to the epiglottis 2063. In humans, the conditionssurrounding sleep disordered breathing involve a relaxed tongue 2051during sleep. In horses the situation is quite different: the tongue2051 and other upper airway structures are much larger and are maximallyactive. Therefore, the tissue retractor 2001 (e.g., the LTR) must beadapted to these harsher conditions. Moreover, in horses secureprevention of backward movement of the tongue 2051 does not allow normalswallowing. Therefore it is necessary that the tissue retractor 2001 beused only when necessary to avoid upper airway obstruction (e.g., DDSP).For example, the tissue retractor 2001 can be loaded immediately beforeexercise and then unloaded immediately after exercise. Moreover theloading and unloading of the tissue retractor 2001 needs to be done bythe trainer, with or without the cooperation of the horse.

Referring now to FIGS. 20C-20D, in some embodiments, a tissue retractor2001 (e.g., an LTR) is used to prevent movement of the tongue 2051backwards preventing backward movement of the tongue 2051 preventsdorsal displacement of the soft palate 2066 in a horse. The situation inthe breathing disordered equine patient differs in many substantial waysfrom that of the breathing disordered human. In horses, the problemoccurs when the animal is awake and exercising at its full capacity. Itis believed that the tongue 2051 base 2053 moves backward and pushes thesoft palate 2066 out of its normal position where it is interlocked withthe epiglottis 2063 (this is shown in FIG. 20B). Therefore the tongue2051 retracting forces needed in horses are much higher than the tongueretracting force used in humans. For example, the amount of forceemployed to retract the horses tongue 2051 ranges from about 1 gm toabout 50 Kg, from about 10 gm to about 10 Kg, or from about 100 gm toabout 1 Kg. To accommodate and/or exert these high forces the tissueretractor 2001 used in horses employs materials such as, for example,stainless steel or materials of comparable tensile strength to stainlesssteel.

In some embodiments, referring now to FIG. 20C, the tissue retractor2001 spans from the tongue base 2053 through the mandible 2068 where thetissue retractor 2001 can be accessed inside of the horses lip. Theretractor member 2020 is at the tongue base 2053, the retractor member2020 connects to a first end of the shaft 2010. A portion of the shaft2010 passes through the tongue 2051, a portion of the shaft 2010 passesthrough the mandible 2068, and the second end of the shaft connects tothe anchor member 2030, which is adjacent the mandible 2068. In oneembodiment, a portion of the shaft 2010 reaches through the mandible2068 to an adjustable anchor member 2030 in front of the mandible 2068.Optionally, a bolster can be placed to load the tissue retractor 2001prior to exercise. In one embodiment, a bolster is placed between themandible 2068 and the anchor member 2030. In another embodiment, abolster is placed between the tongue base 2053 and the retractor member2020.

FIG. 20D shows an embodiment of the tissue retractor 2001 that takesadvantage of certain unique circumstances present in horses.Specifically, a bridle is usually placed on the horse's head when racingto control the horse. Most bridle's have a bit 2067, a bar which passesacross the horse's mouth. This bit 2067 can be used as modified anchorto couple to and load the tissue retractor 2001. Referring still to FIG.20D, the tissue retractor 2001 passes from the tongue base 2053 to thesuperior surface of the tongue 2051. The tissue retractor 2001 isunloaded most of the time and only becomes loaded when it is connectedto the bit 2067 of the horse's bridle prior to exercise. In oneembodiment, the shaft 2010 connects to an anchor member 2030 on thetongue 2051 surface, which is reversibly attached to the bit 2067 of abridle during exercise. The retractor member 2020 is at the tongue base2053. Once the anchor member 2030 of the tissue retractor 2001 is loadedinto the bit 2067, the tongue base 2053 is retracted by the retractormember 2020.

In some embodiments, referring now to FIGS. 20E-20F, the soft palate2066 and the epiglottis 2063 are secured together. In some embodiments,a tissue retractor 2001 (i.e., an LTR) passes from the soft palate 2066to the epiglottis 2063 to resist displacement of the soft palate 2066and the epiglottis 2063. In other embodiments, the tissue retractor 2001passes from the soft palate 2066 to the epiglottis 2063 and restores theinterlocked configuration between the soft palate 2066 and theepiglottis 2063 if the two should become displaced. In one embodiment,referring now to FIGS. 20E-20F, a tissue retractor 2001 directly opposesdislodging the soft palate 2066 from its normal position. An anchormember 2030 is positioned in front of the soft palate 2066, a portion ofthe shaft 2010 passes backward through the soft palate 2066 and thenanother portion of the shaft 2010 passes through the epiglottis 2063 toa retractor member 2020 on the laryngeal surface of the epiglottis 2063.A first end of the shaft 2010 is connected at or near the anchor member2030 and a second end of the shaft 2010 is connected at or near theretractor member 2020. Referring now to FIG. 20G, in one embodiment, atissue retractor 2001 b, 2001 c is positioned through each PGF 2057 andeach tissue retractor 2001 b, 2001 c attaches to a lateral aspect of thesoft palate 2066. In addition, a tissue retractor 2001 a (similar to thetissue retractor show in FIGS. 20E and 20F) may also be positioned tosecure the soft palate 2066 and the epiglottis together.

Referring now to FIGS. 20A-20G, methods of treatment of a breathingdisorder in a horse include, for example, inserting a shaft 2010 into ahorses tongue 2051, connecting a retractor member 2020 at or near afirst end of the shaft 2010, and connecting an anchor member 2030 at ornear a second end of the shaft 2010. The anchor member 2030 is externalto the horses mandible 2068. At least one of the shaft 2010, theretractor member 2020, and the anchor member 2030 interact to exert apressure that prevents obstruction of the horses airway to airflow 2069.A tissue retractor 2001 for treatment of a breathing disorder in a horsecan include a shaft 2010 sized for insertion into a horses tongue 2051,a retractor member 2020 connected at or near a first end of the shaft2010, and an anchor member 2030 connected at or near a second end of theshaft 2010, the anchor member 2030 is external to the horses mandible2068 and at least one of the shaft 2010, the retractor member 2020, andthe anchor member 2030 interact to exert a pressure that preventsobstruction of the horses airway.

Referring now to FIG. 20D, some methods for treatment of a breathingdisorder in a horse include inserting a shaft 2010 into a horses tongue2051, connecting a retractor member 2020 at or near a first end of theshaft 2010, and connecting an anchor member 2030 at or near a second endof the shaft 2010, the anchor member 2030 is external to the horsestongue 2051. The anchor member 2030 is hooked to a bit 2067 of thehorses bridal. Hooking the anchor member 2030 to the bit 2067 “loads”the tissue retractor 2001. At least one of the shaft 2010, the retractormember 2020, the anchor member 2030, and the bit 2067 interact to exerta pressure that prevents obstruction of the horses airway to airflow2069. A tissue retractor for treatment of a breathing disorder in ahorse includes a shaft 2010 sized for insertion into a horses tongue2051, a retractor member 2020 connected at or near a first end of theshaft 2010, and an anchor member 2030 connected at or near a second endof the shaft 2010, the anchor member 2030 is external to the horsestongue 2051 and the anchor member 2030 hooks to a bit 2067 of a horsesbridal. At least one of the shaft 2010, the retractor member 2020, theanchor member 2030, and the bit 2067 interact to exert a pressure thatprevents obstruction of the horses airway to airflow 2069.

Referring now to FIGS. 20E-20F, a method for treatment of a breathingdisorder in a horse includes inserting a shaft 2010 through anepiglottis 2063 and a soft palate 2066, connecting a retractor member2020 at or near a first end of the shaft 2010, the retractor member 2020is external to the soft palate 2066, and connecting an anchor member2030 at or near a second end of the shaft 2010, the anchor member 2030is external to the epiglottis 2063. At least one of the shaft 2010, theretractor member 2020, and the anchor member 2030 interact to maintainthe epiglottis 2063 adjacent to the soft palate 2066 and to preventobstruction of the horses airway.

The method for treatment can also include, referring now to FIG. 20G,positioning a first tissue retractor 2001 a between the epiglottis andthe soft palate 2066 and positioning a second tissue retractor 2001 bsuch that a retractor member is in the region of the pharyngoglossalfold 2057 and at least a portion of the anchor member is attached to thesoft palate 2066. Optionally, a third tissue retractor 2001 c ispositioned such that a retractor member is in the region of the otherpharyngoglossal fold 2057 and at least a portion of its anchor member isattached to the soft palate 2066. At least one of the first tissueretractor 2001 a, the second second tissue retractor 2001 b and thethird tissue retractor 2001 c interact to distribute a force and toprevent obstruction of the horses airway.

10. Non-Invasive Embodiments

Disclosed here, for example, a FIGS. 21A-21H and 22A-22H, are methodsand devices for non-invasively retracting mucosa and displacing softtissue volume for the treatment of sleep apnea and related disorders. Amajor advantage of these non-invasive retraction methods is that nosurgical procedure is needed, and suitable non-invasive devices can beeasily inserted and removed by, for example, the patient or the treatingmedical professional.

At present the only effective non-invasive therapy for sleep apnea isCPAP. CPAP displaces the soft tissue with air pressure and, althougheffective in many cases, it is uncomfortable for the patient and has avery low compliance rate. FIG. 4D depicts the mechanism by which CPAPrelieves airway obstruction. The only other non-invasive therapies whichhave some effect on sleep apnea are dental devices. Other effectivenon-invasive therapies include the use of dental devices that work bymoving the jaw down and forward, thereby indirectly moving the entirefloor of mouth and tongue. By this method the airway is expanded and themucosa connecting the jaw to the pharynx is slightly stretched andstiffened. Unfortunately, the joint connecting the jaw to the skull canonly be stretched a small amount so that there is a limit to how muchthe airway can be expanded. Therefore, at present, dental devices areonly effective in some mild sleep disorder cases. FIG. 4E depicts themechanism by which a dental device relieves airway obstruction.

It is counterintuitive that any tissue retractor device could retractthe tongue and other soft tissue in a patient's mouth without puncturingmucosa. The tongue and pharynx are highly sensitive to contact and anystimulation of the tongue and/or pharynx can cause gagging. Moreover,the whole region within the patient's mouth is covered with slipperymucosa and is always moving. Therefore, it is contrary to expectationthat a non-invasive retraction device can remain in place in the softtissue of a patient's mouth without some firm anchoring to tissue.

In one non-invasive embodiment referring now to FIGS. 21B-21C and21G-21H a portion of a tissue retractor 2101 pushes or tugs on the PGF2157 to retract the PGF 2157 thereby avoiding airway obstruction toairflow 2169. More specifically, the retractor member 2120 lies withinthe groove formed by the base 2153 of the tongue 2151 and the lateralpharyngeal wall 2165. A portion of the retractor member 2120 contactsthe PGF 2157, for example, a portion of the retractor member 2120contacts along the vertical back surface of the PGF 2157.

In one embodiment the retractor member 2120 is thin, soft and formfitted to comfortably distribute force to the mucosa of the PGF 2157.The retractor member 2120 can be made of any of a number of materialssuited to placement in a patient's oral cavity or pharynx, anon-limiting example is a soft gel-like silicone such as, for example,NuSil Technology MED-6380 firm RTV gel, available from NuSil TechnologyLLC, Carpinteria, Calif. The retractor member 2120 can extend solely inthe region of the PGF 2157. Alternatively, the retractor member canextend from the region of the PGF 2157 downward as far as the esophagus.In some embodiments the retractor member 2120 is sized to retract fromthe PGF 2157 to one or more of the upper esophageal spincter, thepyriform sinuses, the vocal folds, the aryepiglottic folds, theepiglottis and/or the lateral pharyngeal walls. Retractor members 2120are sized in accordance with the desired placement and the desiredextent of retraction force. The length of the retractor member 2120 canrange from about 1 mm to about 100 cm, from about 0.5 cm to about 5 cm,and from about 1 cm to about 2 cm.

Retractor members 2120 are shaped to suit the region of placement anddesired extent of retraction in accordance with patient anatomy.Suitable retractor members 2120 have a wedge shape or triangle shape asshown in FIG. 21H. In one embodiment, the widest plane of the wedgeshaped retractor member 2120 ranges from about 1 mm to about 10 mm wide.In one embodiment, a retractor member 2120 is sized to (e.g., the wedgeshaped retractor member widest plane) compresses the tongue base 2153and decreases its compliance, thereby helping to prevent posteriorcollapse of the tongue base 2153. The retractor member 2120 (e.g., thewider base) can then also coax the tongue base 2153 anteriorly (FIG.21G-21H). The retractor member 2120 can have other shapes including, butnot limited to, the shapes described in FIGS. 9A-9D.

The retractor member 2120 can be the shape of a hook and the retractormember 2120 can be used at many sites disclosed herein. To remain inplace without movement the hook shaped retractor member 2120 should be“loaded” to exert retraction force while in position. Positioning theretractor member 2120 at the PGF 2157 site is advantageous, because theretractor member 2120 is surrounded by tissue on all sides of the PFG2157 and even the top of the retractor member 2120 is covered by theoverhanging lateral part of the tongue 2151. In one embodiment,referring now to FIG. 21C, the retractor member 2120 has the shape of ahook and the retractor member 2120 hooks the PGF 2157 much likeeyeglasses hook over the ear. The hook shaped retractor member 2120exerts a force on the PGF 2157 that avoids the obstruction of thepatient's airway. The muscles that pass from the lateral pharyngealwalls into the tongue act as a portion of a spinchter that provides andprevents access to the airway, such as during swallowing. The tissueretractors disposed on the various regions of soft tissue pull thisspinchter open thereby to maintain opens of the patient's airway.

The tissue retractor 2101 retractor member 2120 is connected to thefirst end of the shaft 2110 and its anchor member 2130 is connected tothe second end of the shaft 2110. In some embodiments the shaft 2210passes directly from the top of the retractor member 2120 over the PGF2157 to connect via the anchor member 2130 with one or more of anchoringsites. Suitable anchoring sites include, for example, the patient'steeth and particularly the molars. The teeth 2198 and specifically themolars are at a relatively short distance from the PGF 2157. Forexample, molar teeth are at a distance of from about 1 mm to about 5 cmfrom the PGF 2157. Alternatively, the anchor member 2130 may be anchoredto one or more dental appliances that are well known in the art.Suitable dental appliances can be anchored to teeth (e.g., molar teeth),the patient's gums, dental posts, or dental bridges.

The anchor member 2130 can couple to one or more of the patient's teeth2198. For example, the anchor member 2130 can surround all or a portionof a patient tooth 2198. In one embodiment, the anchor member 2130 hasthe shape of a hook and surrounds at least a portion of the tooth 2198(see, e.g., FIG. 21G-21H).

Dental appliances can have a wide variety of mechanisms to attach to theshaft 2110 or to an anchor member 2130. One method suitable forattaching the shaft 2110 to the a dental appliance or to a patient'steeth include the use of rubber bands, for example, rubber bands similarto those typically used in orthodontics. In one embodiment, a tissueretractor 2001 employs a orthodontic rubber band as its anchor member2130 and the rubber band reversibly couples to a dental appliance in thepatient's mouth. In another embodiment, a tissue retractor 2001 employsa rubber band as its shaft 2110, for example, one portion of a rubberband reversibly attaches to a portion of a retractor member 2120 that isplaced in the region of the PGF 2157 and another portion of the rubberband reversibly attaches to an anchor member 2130 that couples to amolar. The advantage of the embodiment employing a removable shaft 2110is that the shaft 2110 device (e.g., a rubber band) is easily removableand replaceable, completely adjustable, and the distance traveled by theshaft 2110 between the retractor member 2120 and the to anchor member2130 could be very short, thereby achieving the goal of retraction ofthe PGF 2157 with minimal patient discomfort.

Referring now to FIGS. 21D-21F and 22A-22H, in another embodiment atissue retraction clamp 2193, 2293 is designed to remain attached to amucosal fold 2159, 2259 such as a tissue fold in a patient's oral cavityor pharynx by non-invasive means. The tissue retraction clamp 2193, 2293can remain attached to the tissue fold for a limited amount of time, or,optionally, the tissue retraction clamp 2193, 2293 can remain attachedto the tissue fold indefinitely. In one embodiment, the tissueretraction clamp 2193, 2293 is clipped over (e.g., it surrounds) amucosal fold 2159 in the oral cavity or pharynx such that that it canremain in place for extended periods or time. Mucosal folds 2159, 2259are malleable such that compression of the mucosal fold 2159, 2259 withthe clamp 2159, 2259 indents at least a portion of the tissue of themucosal fold 2159, 2259 and maintains the clamp 2159, 2259 substantiallyin its position on the mucosal fold 2159, 2259 such that the clamp 2159,2259 resists migration out of position. (See, e.g., FIGS. 21D-F and22A-22C).

Referring now to FIGS. 21D and 22A, in some embodiments, the tissueretraction clamp 2193, 2293 is sized for placement in a patient's upperairway on, for example, a mucosal fold 2159, 2293 located in thepatient's upper airway. In one embodiment, the clamp 2193, 2293 includesa first arm 2194, 2294 and a second arm 2195, 2295. A shaft 2110, 2210can connect the first arm 2194, 2294 and the second arm 2195, 2295. Forexample, the first arm 2294 is connected at or near a first end of theshaft 2210 and the second arm 2295 is connected at or near a second endof the shaft 2210. In some embodiments, referring now to FIGS. 21E-21Fand 22A-22B, the clamp 2193, 2293 includes a first magnet 2191, 2291that is attracted to a second magnet 2192, 2292. The second magnet 2192,2292 can have a polarity opposite to the first magnet 2191, 2291,alternatively, the second magnet 2192, 2292 can be made of a material(e.g., a suitable non ferrous material) to which the first magnet 2191,2291 is attracted. In some embodiments, referring now to FIG. 22A, thefirst magnet 2291 is connected at or near a first end of the shaft 2210and the second magnet 2292 is connected at or near a second end of theshaft 2210.

Mucosal folds 2159, 2259 are malleable and compression by the clamps2193, 2293 indents the tissue fold and resists migration of the clamps2193, 2293 out of position. In one embodiment, the ends of the arms2194, 2195, 2294, 2295 exert a compressive force on the mucosal folds2159, 2259. In one embodiment, the compressive force is mechanical.Suitable mechanical forces may be generated by the plastic physicalproperties of all or a portion of the clamp 2193, 2293. In someembodiments, a spring is incorporated into the clamp 2193, 2293, forexample on one or more of the first arm 2194, 2294 and the second arm2195, 2295. In one embodiment, all or a portion of the clamp 2193, 2293includes nitinol or other material that maintains force. Optionally,portions of the clamp 2193, 2293 contain magnets (or a magnet and a nonferrous material) that create a force of attraction when brought inproximity to one another. In another embodiment, the clamp 2193, 2293 isloaded at its apex and the arms 2194 and 2195 or 2294 and 2295 areattracted to one another by a spring mechanism similar to what found ina paper clip.

Referring now to FIGS. 21A-21H and 22A-22H, a method for treatment of abreathing disorder includes positioning a clamp 2193, 2293 sized forplacement in a patient's upper airway on a mucosal fold 2159, 2259located in a patient's upper airway and compressing the mucosal fold2159, 2259 with the clamp 2193, 2293 at a pressure that substantiallymaintains the clamp 2193, 2293 in its position on the mucosal fold 2159,2259. The clamp 2193, 2293 indents at least a portion of the mucosalfold 2159, 2259 to prevent obstruction of the patient's airway. In someembodiments, the clamp 2193, 2293 exerts a pressure that is not greaterthan the perfusion pressure of the mucosal fold 2159, 2259. In someembodiments, the clamp has a first magnet 2191, 2291 and a second magnet2192, 2292 of opposite polarity, more specifically, the first magnet2191, 2291 is connected at or near a first end of a shaft 2110, 2210 andthe second magnet 2192, 2292 of opposite polarity is connected at ornear a second end of the shaft 2110, 2210. In some embodiments, theclamp 2193, 2293 has a first arm 2194, 2294 connected at or near a firstend of a shaft 2110, 2210 and a second arm 2195, 2295 connected at ornear a second end of the shaft 2110, 2210, the first arm 2194, 2294 isattracted to the second arm 2195, 2295 by a spring force. In someembodiments, the clamp 2193, 2293 has a shaft 2110, 2210 that exerts atleast one of a protracting or a retracting force on the mucosal fold2159, 2259.

In some embodiments, a tissue clamp 2193, 2293 for treatment of abreathing disorder includes a first arm 2194, 2294 connected at or neara first end of a shaft 2110, 2210 and a second arm 2195, 2295 connectedat or near a second end of the shaft 2110, 2210. The first arm 2194,2294, the second arm 2195, 2295 and the shaft 2110, 2210 are dimensionedto surround a mucosal fold 2159, 2259 located in a patient's upperairway. The first arm 2194, 2294 is attracted to the second arm 2195,2295 by a force and the force indents at least a portion of the mucosalfold 2159, 2259 to prevent obstruction of the patient's airway. Theforce can be, for example, a magnetic force or a spring force.

In one embodiment, referring now to FIG. 21F, a clamp 2193 has a firstmagnet 2191 and a second magnet 2192 that is attracted to the firstmagnet 2191 thereby to create an attraction force that indents themucosal fold 2159. In one embodiment, a first end of a shaft 2110A hasthird magnet 2110B and the third magnet 2110B is attracted to at least aportion of the clamp 2193. For example, the third magnet 2110B isattracted to the second magnet 2192. Optionally, the shaft 2110A and itsthird magnet 2110B are brought into proximity to the clamp 2193 therebyto move the mucosal fold 2159 in a direction that creates an indentationin at least a portion of the mucosal fold to prevent obstruction of thepatient's airway. In some embodiments, the shaft 2110A is attached to ananchor member such as, for example, an anchor member that anchors abouta dental structure such as, for example, a tooth. In some embodiments, aclamp 2193 placed surrounding a mucosal fold 2159 a patient's oralcavity or pharynx and when the patient seeks to “load” the tissueretractor the clamp 2193 becomes the retractor member, the magnet 2110Bat the first end of the shaft 2110A is brought in proximity to the clamp2193 and attracts to the clamp 2193, the second end of the shaft 2110 isconnected to an anchor member, for example, the second end of the shaft2110 is attached to an anchor member having a hook shape that surroundsat least a portion of the patient's tooth. Accordingly, referring now toFIGS. 21F and 22F, magnets can be used to reversibly couple a clamp2193, 2293, to an anchor member 2230 via a shaft 211A, 2210. In oneembodiment, the clamp 2193, 2293 compresses the mucosa (e.g., themucosal fold 2159, 2259) and the retraction via the anchor member 2230and the shaft 2210 retracts the edge of the tissue fold.

In some embodiments, the tissue retraction clamp 2193, 2293 is clippedover (e.g., it surrounds) a mucosal fold 2159, 2259 in the oral cavityor pharynx such that that it can remain in place for extended periods ortime without connection to an anchor (FIGS. 21C-21E and 22A-22D). In oneembodiment, referring now to FIG. 22C, the clamp 2293 includes a shaft2210 connected at each end by an arm (e.g., the first arm 2294 and thesecond arm not shown in this figure). The clamp 2293 surrounds themucosal fold 2259 and both compresses the mucosa and retract the edge ofthe soft tissue fold.

In some embodiments, multiple clamps are employed. Referring now to FIG.22D, two clamps 2293A and 2293B are connected by a shaft 2210C thatexerts force in an expanding direction between the clamps 2293A, 2293B.For example, the force provided by the shaft 2210C can protract orlengthen the soft tissue. In some embodiments, two clamps are employedto protract or lengthen tissue without use of a shaft therebetween.

In some embodiments, referring to FIGS. 22D and 22H, a method fortreatment of a breathing disorder includes positioning a clamp 2293Asized for placement in a patient's upper airway on a mucosal fold 2259located in a patient's upper airway and compressing the mucosal fold2259 with the clamp 2293A at a pressure that substantially maintains theclamp 2293A in its position on the mucosal fold 2259. Positioning asecond clamp 2293B sized for placement in the patient's upper airway onanother portion of the mucosal fold 2259 and compressing the otherportion of the mucosal fold 2259 with the second clamp 2293B at apressure that substantially maintains the second clamp 2293B in itsposition on the other portion of the mucosal fold 2259. The clamp 2293Aindents at least a portion of the mucosal fold 2259 and the second clamp2293B indents at least a portion of the other portion of the mucosalfold 2259 and the clamp 2293A and the second clamp 2293B exert a force(e.g., a protracting force) between the mucosal fold 2259 and the otherportion of the mucosal fold 2259 to prevent obstruction of the patient'sairway. In one embodiment, a shaft 2210C is disposed between the clamp2293A and the second clamp 2293B, the shaft 2210C exerts at least one ofa protracting or a retracting force on the mucosal fold 2259.

The non-invasive retractor clamp(s) 2193, 2293 can be used in all siteswithin the upper airway where mucosal folds 2159, 2259 are present orwhere mucosal folds 2159, 2259 can be formed by grasping tissue. Theseupper airway sites include without limitation, the PGF, the frenulum,the lateral tongue surface, tonsillar folds (FIGS. 22E-22F), the softpalate (FIG. 22G), the pharyngeal walls, the floor of the mouth, and thearyepiglottic fold. In some embodiment, indentation of the mucosal foldmaintains all or a portion of the patient's airway in the open position.Some of these sites within the patient's upper airway have extensivesensory innervation, however, so long as the contact between the clamp2193, 2293 and mucosa is stable and immobile the sensation disappearswithin minutes after placing the clamp 2193, 2293 about the mucosal fold2159, 2259. This loss of sensation is called habituation and is wellknown to sensory physiologists. The stability of contact between theretractor clamp and the region of mucosa can be increased by the use ofadhesives known in the art. Adhesives effective on mucosa can include,but are not limited to, fibrin, hydrogels, and cyanoacrylic glues. It isalso important that the site for the clamp 2193, 2293 as well as theshaft 2110, 2210 and the anchor 2130, 2230 be placed such that the leastamount of dynamic contact occurs between these various components andthe mucosa. In addition, when a clamp 2193, 2293 is used on an ongoingbasis the compression exerted by the clamp 2193, 2293 (e.g., thecompression between the arms of the clamp 2193, 2293) should not exceedthe pressure at which capillary blood circulation stops, called theperfusion pressure, which is about 25 mm Hg or 34 cm H₂O.

Referring now to FIGS. 23A-23L, other non-invasive methods and devicesfor soft tissue and/or mucosa protraction and/or retraction use vacuumand/or bolsters to displace, protract, and/or to retract soft tissue.FIG. 23A is a side view showing a patient's floor of mouth 2376 thatextends from the mandible 2368 to the hyoid bone 2377. FIG. 23B is afront view showing that the floor of mouth 2376 connects to the bottomof each side of the mandible 2368. FIG. 23C is a top view showing thetongue 2351 and the triangular root 2349 of the tongue below the tongue2351. The anterior extension of the root 2349 is the genioglossus muscle2363 (seen in FIGS. 23A and 23B) that inserts into the mandible 2368.

Another embodiment of this invention is to increase the pharyngealairspace by depressing the floor of the mouth. The floor of the mouth2376 is composed of muscles and other soft tissue that attaches to thehyoid bone 2377 posteriorly and attaches to the mandible 2368 anteriorlyand laterally. The tongue 2351 sits on the floor of the mouth 2376 andfollows its movements. For example when the jaw is moved forward ordownward the tongue 2351 moves along with it. Similarly when the hyoidbone 2377 moves forward it displaces the back of the tongue in the samedirection. Some surgical procedures try to take advantage of thisrelationship by wiring the hyoid bone 2377 in a more forward position bywiring it to the front of the mandible 2368. Unfortunately, the hyoidbone 2377 has many other attachments that resist being repositioned.

In contrast to prior approaches that focus on moving the bonyattachments of the floor of the mouth 2376, in one embodiment, the softtissue of the floor of the mouth 2376 is moved/repositioned.Specifically, in one embodiment, the bottom of the tongue (i.e., theroot of the tongue 2349) that rests on the floor of the mouth 2376 istriangular shaped and smaller then the overall area of the floor of themouth 2376 (FIG. 231). Therefore the floor of the mouth 2376 can bereached between the tongue root 2349 and the mandible 2368. When thearea between the tongue root 2349 and the mandible 2368 is depressed theroot of the tongue 2349 is depressed as well. Although the entireexposed floor of the mouth 2376 can be depressed, this is inefficient,as the most important area to move is the tongue base.

Referring now to FIG. 23D a bolster 2340 is pushed downward and slightlyanterior by a shaft 2310. The shaft 2310 and the bolster 2340 exert aprotracting force on the floor of mouth 2376. The protracting forceindents the floor of mouth 2376, which alters the position of the tongue2351 and the PGF 2357. Referring now to FIG. 23E, the floor of mouth2376 is depressed by the bolster 2340, which creates room that depressesthe tongue 2351 by the same amount that the floor of the mouth 2376 isdepressed, which results in a decreased height of tongue 2351 surfaceat, for example, the tongue curve. Referring now FIG. 23F, the bolster2340 is seen from above. Note the anterior displacement of the base ofthe tongue 2351 that results from use of the bolster 2340.

In one embodiment, the area of the floor of the mouth 2376 around thetongue base is depressed thereby moving the tongue base down and as aresult of the downward movement of the tongue base the pharyngealairspace is increased. For practical purposes the PGF 2357 places alimit on how far back the floor of the mouth 2376 can be reached. In oneembodiment a tissue retractor with a silicon bolster 2340 measuring 0.5cm×0.5 cm×1 cm is situated longitudinally alongside the undersurface ofthe tongue 2351 with one end abutting the PGF 2357. In one embodiment,downward pressure exerted on the bolster 2340 is achieved by a dentalappliance attached to the molar teeth or a palatal prosthesis that isconnected to the bolster 2340 by, for example, the shaft 2310. Thedownward pressure exerted on the bolster 2340 depresses the floor of themouth 2376. The bolster 2340 exerts a protracting force on the floor ofthe mouth 2376. Not all the downward movement of a local area of floorof mouth 2376 depression is transferred to the tongue 2351. However, anincrease in the pharyngeal airspace that avoids obstruction of thepatient's airway is beneficial.

In addition to depression of the floor of the mouth 2376, thedisplacement force can be exerted forward (anterior), inward (medial) oroutward (lateral). Forward displacement is beneficial, because thepharyngeal airspace is expanded to the extent that the tongue base alsomoves forward. Inward movement is beneficial if both sides exert agrasping force on the tongue 2351 and thereby resist backward tonguecollapse. Outward movement is also beneficial to the extent that theoutward movement stretches and tenses tongue tissue thereby alsopreventing backward tongue collapse.

Non-invasive coupling to mucosa in the oral cavity or pharynx isdifficult. Reversible non-invasive coupling may be accomplished by usingvacuum to suck a volume of mucosa into the vacuum opening. FIG. 23Gshows a vacuum device 2347 retractor member 2320 applied to the lateraltongue 2351. The vacuum device 2347 is positioned below the tongue 2351adjacent the floor of mouth 2376 and the PGF 2357. FIG. 23H shows avacuum device 2347 employed as a retractor member 2320 that displacestongue 2351 tissue. Use of the vacuum device 2347 results in tongue 2351tissue displacement that is reflected by the decreased height of thetongue 2351 surface. FIG. 23I shows a vacuum device 2347 employed as aretractor member 2320 that displaces tongue 2351 tissue and results inanterior displacement of the base of the tongue 2351 that avoidsobstruction of the airway due to collapse of the tongue 2351 toward thesoft palate 2366 (see FIG. 23G).

Referring now to FIGS. 23G-23I, vacuum can be applied through suction orvacuum devices 2347 placed over segments of the tongue 2351 to causedisplacement of tongue 2351 tissue into the suction. Because the volumeof a patient's tongue 2351 is constant, the use of suction on the tongue2351 tissue displaces a portion of tongue 2351 tissue and the displacedtongue 2351 tissue is moved from other parts of the tongue 2351. In oneembodiment, suction is employed on a portion of a patient's tongue 2351tissue and displaces tongue 2351 tissue from the tongue base. Vacuum canbe used to displace soft tissue volume, for example, vacuum can be usedon the tongue 2351 by a relatively large device that sucks tissue volumeinto the vacuum device 2347 and thereby changes the shape of the tongue2351 such that volume is removed from the tongue base. Referring now toFIGS. 23G-23I, in one embodiment a retraction member 2320 is a vacuumdevice 2347 that is applied to the lateral tongue 2351. The vacuumdevice 2347 is positioned below the tongue 2351 adjacent the floor ofmouth 2376 and the PGF 2357. The vacuum device 2347 vacuums anddisplaces a portion of the tongue 2351 tissue. The displacement of thetongue 2351 tissue is reflected by the decreased height of the tongue2351 surface (see FIG. 23E). The vacuum device 2347 tongue 2351 tissuedisplacement results in anterior displacement of the base of the tongue2351 thereby to avoid obstruction of the airway due to collapse of thetongue toward the soft palate 2366 (see FIG. 23G).

Vacuum can be employed through suction devices that can be used tosuction a retractor member onto a mucosal surface thereby tonon-invasively attach the retractor member within the patient's oralcavity or pharynx. In one method, vacuum device 2347 is used to couple aretractor member to mucosa in the patient's oral cavity or pharynx. Inone embodiment, the vacuum device 2347 is a retractor member 2320 thatis applied to the PGF, for example, to the anterior surface of the PGF.Other suitable sites for placement of a vacuum device 2347 retractormember 2320 are the lateral and/or inferior tongue surface. Vacuumretraction may be applied to any suitable tissue and/or mucosa surfaceat a location in the oral cavity or pharynx where tissue retraction isbeneficial to prevent patient airway obstruction.

FIG. 23J shows a view of another vacuum device 2347. FIG. 23K shows aclose up view of the vacuum device 2347 of FIG. 23J employed as a tissueretractor. FIG. 23L shows a close up view of the vacuum device 2347 ofFIG. 23K employed as a tissue retractor. Once this tissue is pulled intothe vacuum device 2347 its interface with the walls of the vacuum device2347 directly locks the tissue 2350 in place within the interior walls.In other words, if the retractor member 2320 is pulled in a lateraldirection, the tissue 2350 is pulled also. The vacuum mechanism can beused in place of or in addition to embedded magnets, clips, or othertissue retraction devices. The vacuum device 2347 retractor member 2320can include a suction cup of the type well known in the art and thevacuum is formed by pressing the suction cup against the patient'smucosa.

Referring now to FIGS. 23L-23N, in one embodiment, the interface betweenthe suction device and the mucosa has well defined edges with interiorwalls of the vacuum device 2347 having an angle 2354 of between about120° or less. In one embodiment, the angle 2354 is about 90°. In anotherembodiment, the angle 2354 is about 45°.

In one embodiment, referring now to FIGS. 23J and 23K, the vacuum device2347 is connected via a tube 2311 to a vacuum source, for example. Thetube 2311 allows vacuum to be delivered to the tissue 2450. The vacuumdevice 2347 can be many sizes and shapes, a simple embodiment is a roundopening 1 cm in diameter with inner walls 5 mm in depth. In oneembodiment, the vacuum travels from a vacuum source via a tube 2311 tothe vacuum device 2347, which is positioned in the patient's mouth. Inanother embodiment the vacuum device 2347 is attached to a small airpump located and/or positioned in the patient's mouth.

Small electric pumps within the mouth can also be a source of vacuum.The air pump may be passive, composed, for example, of a small bladderwith a one way valve such that movements of the tongue or jaw thatcompress the bladder force air out of the bladder through the one wayvalve. The elastic drive of the bladder to return to its larger volumeshape forms the vacuum that attaches to tissue and/or that displacestissue volume. The vacuum can be from a source inside the mouth andhooked to the vacuum device 2347 at some convenient spot via a tube. Theamount of vacuum is sufficient to draw tissue into the coupler but notcause damage. Preferably this ranges from 0.1 to 100 cm of waterpressure, in some embodiments, from 1 to 10 cm of water pressure.

The vacuum device 2347 is applied to a site to be moved and then vacuumis applied by the vacuum device 2347. Turning off the vacuum or breakingthe seal allows the vacuum device 2347 to disengage. In one embodiment,the maintenance of vacuum without leakage is aided by placingbiocompatible viscous material in the area of soft tissue that contactsthe inner walls of the vacuum device 2347. An example of suchbiocompatible viscous material is the patient's own mucous.

In some embodiments, the vacuum device 2347 is attached to a modifiedanchor. In one embodiment, after a vacuum device 2347 couples to themucosa it is displaced forward by a shaft. The vacuum device 2347 canhave a single suction interface or, referring to FIG. 23L, multiplesmaller suction interfaces 2348 a, 2348 b etc. (e.g., mini suctioncups). Viscous mucoid material or adhesive could be applied to themucosa to aid in maintaining a seal between the mucosa and the vacuumdevice 2347. Referring now to FIGS. 23J-23N, in one embodiment, a vacuumdevice 2347 includes one or more suction cup that suctions small amountsof tissue into the suction cup opening. The presence of the suction cupprovides resistance to shear forces acting at the suction site.

FIG. 23L shows a vacuum device 2347 having an angle 2354 of about 90°.It can be seen that the soft tissue 2350 pulled into the vacuum device2347 conforms to the walls of the vacuum device 2347 such that the softtissue 2350 resists lateral movement. FIG. 23M shows another vacuumdevice 2347 having an angle 2354 of about 45°. The 45° angle is a sizesmall enough to trap the soft tissue 2350 within the vacuum device 2347.Further, the edges 2354 a, 2354 b trap the soft tissue 2350 such thatthe soft tissue 2350 resists movement when the angles 2354 measure about45°. In one embodiment, the vacuum device 2347 is attached to a lumenand suction is pulled through the vacuum device 2347 through the lumenof the tube 2311. In some embodiments, the soft tissue 2350 is pulledinto and trapped inside the lumen of the tube 2311. Referring still toFIG. 23M, the edges 2354 a, 2354 b form a rim around a portion of thevacuum device 2347 that prevents movement of the soft tissue 2350. Inthis way, the shape of the vacuum device 2347 shown in FIG. 23M resiststhe soft tissue 2350 from dislodging from the vacuum device 2347.

FIG. 23N shows another vacuum device 2347 having an angle 2354 of about135° as the angle 2354 increases, somewhere around 135°, the wallsand/or the edges 2354 a, 2354 b cannot prevent the soft tissue 2350 fromsliding out of the vacuum device 2347.

Referring now to FIGS. 23L-23N the vacuum device 2347 can grab the softtissue 2350 and in some embodiments, can prevent motion, e.g., lateralmotion, of the soft tissue 2350 by trapping the soft tissue 2350 withinthe vacuum device 2347. In some embodiments, the vacuum device 2347 actsan anchor to which members such as, for example, a shaft and/or aretractor member can be attached. For example, in one embodiment, thevacuum device 2347 is coupled to soft tissue 2350 on the collgeneous topsurface of the tongue where the tongue is stiff and is not easilymovable.

In other embodiments, the vacuum device 2347 grabs soft tissue 2350 suchthat the soft tissue 2350 together with the vacuum device 2347 can bemoved in a direction that avoids blocking airflow. In this way, thevacuum device 2347 may retract soft tissue 2350. For example, the vacuumdevice 2347 grabs soft tissue 2350 on the tip of the patient's tonguesuch that the tongue may be retracted by exerting a pulling force on thevacuum device 2347 and moving an attached shaft 2310 in a desireddirection of retraction.

Some tissue retractors initiate desirable remodeling of the patient'stissue. For example, in an embodiment where the retractor member has ahead that measures between about 2 and about 3 cm in diameter theretractor member head is implanted in tongue tissue. Over a few monthsthe tongue tissue remodels/reshapes to become thinner in the regionexposed to the retractor head. For example, the tongue adapts quickly topressure placed on it. After the tissue retractor has been placed forfrom about 1 to about 2 months the tissue retractor may need to beadjusted to compensate to the thinning of the tongue tissue. In someembodiment, all or a portion of the tissue retractor is designed in amanner that encourages tissue remodeling. Tissue remodeling can bepermanent reshaping of tissue for beneficial effect. Alternatively,tissue remodeling can be semi-permanent reshaping of tissue forbeneficial effect.

It is to be understood that the described embodiments are merelyillustrative and that variations of the above-described embodiments canbe devised by one skilled in the art without departing from the scope ofthe invention. It is therefore intended that all such variations beincluded within the scope of the following claims and their equivalents.

1. A method for treatment of a breathing disorder, the methodcomprising: a) positioning a shaft having a first end and a second endin a patient's oral cavity or pharynx; b) connecting one of a retractormember and an anchor member at or near the first end and in the regionof the pharyngoglossal fold; c) connecting the other of the retractormember and the anchor member at or near the second end of the shaft,wherein at least one of the shaft, the retractor member, and the anchormember interact to distribute a force on at least one of a tongue base,a lateral paryngeal wall, a tonsillar fold, or a soft palate and theforce prevents obstruction of the patient's airway.
 2. The method ofclaim 1 wherein at least a portion of the retractor member or at least aportion of the anchor member is positioned on an external surface of thepharyngoglossal fold.
 3. The method of claim 1 wherein at least aportion of the retractor member or at least a portion of the anchormember is positioned behind the pharyngoglossal fold.
 4. The method ofclaim 1 wherein at least a portion of the retractor member or at least aportion of the anchor member is disposed inside the region of thepharyngoglossal fold.
 5. The method of claim 1 wherein the first end ofthe shaft comprises a first magnet and one of the retractor member andthe anchor member comprises a second magnet or a material that attractsto the first magnet.
 6. The method of claim 1 wherein the anchor membercouples to a tooth.
 7. The method of claim 1 wherein at least a portionof the shaft is internal to at least one of the pharyngoglossal fold anda tongue.
 8. The method of claim 1 wherein at least a portion of theanchor member or at least a portion of the retractor member ispositioned inside the patient's mouth, in the region of the patient'sfrenulum, external to the patient's mouth, adjacent a surface of atongue, inside a tongue, or external to a soft palate.
 9. A tissueretractor for treatment of a breathing disorder, the tissue retractorcomprising: a) a retractor member comprising a first magnet; b) a shaftsized for placement in a patient's oral cavity or pharynx, wherein afirst end of the shaft comprises a second magnet or other material thatattracts to the first magnet; and c) an anchor member connected at ornear a second end of the shaft, wherein at least one of the shaft, theretractor member and the anchor member interact to distribute a force ona soft tissue in the patient's oral cavity or pharynx, and the forceprevents obstruction of the patient's airway.
 10. The tissue retractorof claim 9 wherein the anchor member couples to a tooth.
 11. The tissueretractor of claim 9 wherein the anchor member surrounds at least aportion of the tooth.
 12. A method for treatment of a breathingdisorder, the method comprising: a) positioning a clamp sized forplacement in a patient's upper airway on a mucosal fold located in apatient's upper airway; and b) compressing the mucosal fold with theclamp at a pressure that substantially maintains the clamp in itsposition on the mucosal fold, wherein the clamp indents at least aportion of the mucosal fold to prevent obstruction of the patient'sairway.
 13. The method of claim 12 wherein the pressure is not greaterthan the perfusion pressure of the mucosal fold.
 14. The method of claim12 wherein the clamp comprises a first magnet and a second magnet ofopposite polarity.
 15. The method of claim 12 wherein the clampcomprises a first magnet connected at or near a first end of a shaft anda second magnet of opposite polarity connected at or near a second endof the shaft.
 16. The method of claim 12 a first arm connected at ornear a first end of a shaft and a second arm connected at or near asecond end of the shaft, the first arm is attracted to the second arm bya spring force.
 17. The method of claim 12 wherein the clamp comprises ashaft and the shaft exerts at least one of a protracting or a retractingforce on the mucosal fold.
 18. The method claim 12, the method furthercomprising: c) positioning a second clamp sized for placement in thepatient's upper airway on another portion of the mucosal fold; and d)compressing the other portion of the mucosal fold with the second clampat a pressure that substantially maintains the second clamp in itsposition on the other portion of the mucosal fold, wherein the secondclamp indents at least a portion of the other portion of the mucosalfold and the clamp and the second clamp exert a protracting forcebetween the mucosal fold and the other portion of the mucosal fold toprevent obstruction of the patient's airway.
 19. A tissue clamp fortreatment of a breathing disorder, the tissue clamp comprising: a) afirst arm connected at or near a first end of a shaft; and b) a secondarm connected at or near a second end of the shaft, wherein the firstarm is attracted to the second arm by a force, wherein the first arm,the second arm, and the shaft are dimensioned to surround a mucosal foldlocated in a patient's upper airway, wherein the force indents at leasta portion of the mucosal fold to prevent obstruction of the patient'sairway.
 20. The method of claim 19 wherein the force is a magneticforce.
 21. The method of claim 19 wherein the force is a spring force.22. The method of claim 19 wherein the shaft exerts at least one of aprotracting or a retracting force on the mucosal fold.
 23. A method fortreatment of a breathing disorder, the method comprising implanting intoa tonsillar fold in a patient's oral cavity or pharynx a shaft with aretractor member connected at a first end and an anchor member connectedat a second end, wherein at least one of the shaft, the retractor memberand the anchor member interact to distribute a force on a soft tissue inthe patient's oral cavity or pharynx, and the force prevents obstructionof the patient's airway.
 24. A method for treatment of a breathingdisorder, the method comprising: a) implanting at least a portion of ashaft having a first end and a second end into a tonsillar fold in apatient's oral cavity or pharynx; b) connecting one of a retractormember and an anchor member at or near the first end; and c) connectingthe other of the retractor member and the anchor member at or near thesecond end, wherein at least one of the retractor member and the anchormember is external to the tonsillar fold and at least one of the shaft,the retractor member, and the anchor member interact to distribute aforce that prevents obstruction of the patient's airway.
 25. The methodof claim 24 wherein the force pushes at least a portion of the softpalate to open at least a portion of the patient's airway.
 26. Themethod of claim 24 wherein the anchor member surrounds at least aportion of a tooth.
 27. The method of claim 24 wherein the anchor memberis external to an anterior tonsillar fold.
 28. A method for treatment ofa breathing disorder, the method comprising: a) implanting a firstportion of a retractor member into a soft tissue located in a patient'soral cavity or pharynx, wherein a second portion of the retractor memberis exterior to the soft tissue; b) connecting a first end of a shaft tothe retractor member; and c) connecting an anchor member to a second endof the shaft, wherein at least one of the retractor member, the shaft,and the anchor member interact to exert a pressure that preventsdeformation of at least a portion of the soft tissue that preventsobstruction of the patient's airway.
 29. The method of claim 28 whereinthe shaft is external to the soft tissue.
 30. The method of claim 28wherein the second portion of the retractor member has a low profilewhen not connected to the first end of the shaft.
 31. The method ofclaim 28 wherein at least a portion of the retractor member ispositioned in the region of the pharyngoglossal fold.
 32. The method ofclaim 28 the anchor member comprising an anchor member first portionimplanted in a soft tissue located in a patient's oral cavity or pharynxand an anchor member second portion external to the soft tissue.
 33. Themethod of claim 28 wherein the anchor member comprises a bandsurrounding at least a portion of the external diameter of a patient'stongue.
 34. The method of claim 28 wherein the anchor member comprises astud on an external surface of the patient's tongue.
 35. A tissueretractor for treatment of a breathing disorder, the tissue retractorcomprising: a) a retractor member with a first portion sized forimplantation into a soft tissue located in a patient's oral cavity orpharynx and a second portion sized for placement external to the softtissue; b) an anchor member; and c) a shaft, a portion of the shaftcontacting the second portion of the retractor member and anotherportion of the shaft connecting at or near the anchor member, wherein atleast one of the retractor member, the shaft, and the anchor memberinteract to exert a pressure that prevents deformation of at least aportion of the soft tissue that prevents obstruction of the patient'sairway.
 36. The tissue retractor of claim 35 wherein the shaft isexternal to the soft tissue.
 37. The tissue retractor of claim 35wherein a first end of the shaft connects at or near the anchor member,a second end of the shaft connects at or near a second anchor member,and the portion of the shaft exerts the pressure on the second portionof the retractor member.
 38. The tissue retractor of claim 37, whereinthe anchor member comprises a first magnet, the first end of the shaftcomprises a second magnet that attracts to the first magnet, the secondanchor member comprises a third magnet, and the second end of the shaftcomprises a fourth magnet that attracts to the third magnet.
 39. Thetissue retractor of claim 35 wherein the second portion of the retractormember has a low profile when not contacting the shaft.
 40. The tissueretractor of claim 35 wherein the anchor member comprises a bandsurrounding at least a portion of the external diameter of a patient'stongue.
 41. The tissue retractor of claim 35 wherein the anchor membercomprises a stud on the external surface of a patient's tongue.
 42. Amethod for treatment of a breathing disorder, the method comprising: a)positioning a first anchor member in the region of the firstpharyngoglossal fold; b) positioning a second anchor member in theregion of the second pharyngoglossal fold; and c) connecting a first endof a shaft at or near the first anchor member and connecting a secondend of the shaft at or near the second anchor member, wherein at leastone of the first anchor member, the second anchor member and the shaftinteract to distribute a force on at least a portion of a tongue thatprevents obstruction of the patient's airway.
 43. The method of claim42, wherein the first anchor member comprises a first magnet, the firstend of the shaft comprises a second magnet that attracts to the firstmagnet, the second anchor member comprises a third magnet, and thesecond end of the shaft comprises a fourth magnet that attracts to thethird magnet.
 44. The method of claim 42, the method further comprisinginserting a first portion of a retractor member in the tongue, wherein asecond portion of the retractor member is exterior to the tongue, and atleast a portion of the shaft contacts the second portion of theretractor member.
 45. The method of claim 42, wherein a first portion ofa retractor member is inserted in the tongue, a second portion of theretractor member is exterior to the tongue, and at least a portion ofthe shaft contacts the second portion of the retractor member, whereinat least one of the first anchor member, the second anchor member, theretractor member, and the shaft interact to distribute a force on atleast a portion of the tongue that prevents obstruction of the patient'sairway.
 46. The method of claim 42, wherein at least a portion of theshaft is internal to the tongue.
 47. A method for treatment of abreathing disorder, the method comprising: a) positioning a first anchormember in a first region of soft tissue located in a patient's oralcavity or pharynx; b) positioning a second anchor member in a secondregion of soft tissue located in the patient's oral cavity or pharynx;c) inserting a first portion of a retractor member into a third regionof soft tissue located in the patient's oral cavity or pharynx, whereina second portion of the retractor member is exterior to the third regionof soft tissue; and d) connecting a first end of a shaft at or near thefirst anchor member and connecting a second end of the shaft at or nearthe second anchor member, wherein at least one of the first anchormember, the second anchor member, the retractor member, and the shaftinteract to exert a pressure that prevents deformation of at least aportion of soft tissue to prevent obstruction of the patient's airway.48. The method of claim 47 wherein the first anchor member comprises afirst magnet, the first end of the shaft comprises a second magnet thatattracts to the first magnet, the second anchor member comprises a thirdmagnet, and the second end of the shaft comprises a fourth magnet thatattracts to the third magnet.
 49. The method of claim 47, wherein atleast a portion of the shaft exerts a pressure on the retractor memberthat prevents deformation of the third region of soft tissue.
 50. Amethod for treatment of a breathing disorder, the method comprising: a)inserting at least a portion of a shaft into a patient's tongue; b)connecting a retractor member at or near a first end of the shaft at anexternal surface of the tongue; c) connecting an anchor member at ornear a second end of the shaft; d) surrounding at least a portion of theexternal diameter of the tongue with a band disposed adjacent theretractor member; and e) moving the band to exert a pressure on at leastone of a portion of the retractor member and at least a portion of theshaft to prevent deformation of at least a portion of the tongue so asto prevent obstruction of the patient's airway.
 51. The method of claim50 wherein moving the band comprises rotating the band and pushing atleast a portion of the retractor member and at least a portion of theshaft to displace at least a portion of the tongue so as to preventobstruction of the patient's airway.
 52. A tissue retractor fortreatment of a breathing disorder, the tissue retractor comprising: a) ashaft sized for insertion into a patient's tongue; b) a retractor memberconnected at or near a first end of the shaft, wherein the retractormember is positioned at the external surface of the tongue; c) an anchormember connected at or near a second end of the shaft; and d) a bandsized to surround at least a portion of the external diameter of thetongue, wherein the band moves to exert a pressure on at least one of aportion of the retractor member and a portion of the shaft to preventdeformation of a portion of the tongue so as to prevent obstruction ofthe patient's airway.
 53. The tissue retractor of claim 52 wherein theband is dimensioned to rotate and push at least one of a portion of theretractor member and a portion of the shaft.
 54. A method for treatmentof a breathing disorder with a retractor member connected at or near afirst end of a shaft and an anchor member connected at or near a secondend of the shaft, the method comprising: a) inserting the shaft into apatient's tongue between the superior layer and the middle layer; b)attaching one of the retractor member and the anchor member to themucosa tissue fascia; and c) attaching the other of the retractor memberand the anchor member to the midline septum tissue fascia, wherein atleast one of the shaft, the retractor member and the anchor memberinteract to exert a counterforce pressure that prevents a portion of thepatient's tongue from obstructing the patient's oral cavity or pharynx.55. The method of claim 54 wherein the portion of the patient's tongueis the base of the patient's tongue.
 56. The method of claim 54 whereinone or more of the shaft, the retractor member, and the anchor member isbioresorbable.
 57. The method of claim 54 wherein the portion of thepatient's tongue is the midline of the tongue.
 58. The method of claim54 wherein the middle layer comprises the midline septum.
 59. The methodof claim 54 further comprising positioning the retractor member, theshaft, and the anchor on a needle, inserting the needle to a desireddepth within the patient's tongue, and removing the needle.
 60. A methodfor treatment of a breathing disorder, the method comprising: a)inserting a shaft into a soft palate located in a patient's oral cavityor pharynx; b) connecting a retractor member at or near a first end ofthe shaft; and c) connecting an anchor member at or near a second end ofthe shaft, wherein at least one of the shaft, the retractor member andthe anchor member interact to exert a pressure that prevents deformationof a portion of the soft palate so as to prevent obstruction of thepatient's airway.
 61. The method of claim 60 wherein at least one of theretractor member or the anchor member is on an external surface of thesoft palate.
 62. The method of claim 61 further comprising a band, afirst end of the band connects at or near the retractor member, a secondend of the band connects at or near the anchor member, and the bandexternally surrounds at least a portion of the soft palate.
 63. Themethod of claim 62 wherein at least one of the shaft, the retractormember, the anchor member, and the band interact to exert a pressurethat prevents deformation of a portion of the soft palate so as toprevent obstruction of the patient's airway.
 64. The method of claim 61further comprising disposing a bolster on an external surface of thesoft palate between the external surface of the soft palate and one ofthe retractor member and the anchor member.
 65. A tissue retractor fortreatment of at least one of snoring and sleep apnea, the tissueretractor comprising: a) a shaft sized for insertion into a patient'ssoft tissue; b) a retractor member connected at or near a first end ofthe shaft, the retractor member positioned on an external surface of thepatient's soft tissue; c) an anchor member connected at or near a secondend of the shaft; and d) a band, the band is sized to surround at leasta portion of the external diameter of the patient's soft tissue, a firstend of the band is connected at or near the retractor member, and asecond end of the band is connected at or near the anchor member,wherein at least one of the shaft, the retractor member, the anchormember, and the band interact to exert a pressure that preventsdeformation of a portion of the soft tissue so as to prevent obstructionof the patient's airway.
 66. The tissue retractor of claim 65, whereinthe anchor member is positioned on an external surface of the patient'ssoft tissue.
 67. A method for treatment of a breathing disorder in ahorse, the method comprising: a) inserting a shaft into a horse'stongue; b) connecting a retractor member at or near a first end of theshaft; and c) connecting an anchor member at or near a second end of theshaft, the anchor member is external to the horse's mandible, wherein atleast one of the shaft, the retractor member, and the anchor memberinteract to exert a pressure that prevents obstruction of the horse'sairway.
 68. A tissue retractor for treatment of a breathing disorder ina horse, the tissue retractor comprising: a) a shaft sized for insertioninto a horse's tongue; b) a retractor member connected at or near afirst end of the shaft; and c) an anchor member connected at or near asecond end of the shaft, wherein the anchor member is external to thehorse's mandible and at least one of the shaft, the retractor member,and the anchor member interact to exert a pressure that preventsobstruction of the horse's airway.
 69. A method for treatment of abreathing disorder in a horse, the method comprising: a) inserting ashaft into a horse's tongue; b) connecting a retractor member at or neara first end of the shaft; and c) connecting an anchor member at or neara second end of the shaft, the anchor member is external to the horse'stongue; and d) hooking the anchor member to a bit of a horse's bridal;wherein at least one of the shaft, the retractor member, the anchormember, and the bit interact to exert a pressure that preventsobstruction of the horse's airway.
 70. A tissue retractor for treatmentof a breathing disorder in a horse, the tissue retractor comprising: a)a shaft sized for insertion into a horse's tongue; b) a retractor memberconnected at or near a first end of the shaft; and c) an anchor memberconnected at or near a second end of the shaft, wherein the anchormember is external to the horse's tongue and the anchor member hooks toa bit of a horse's bridal and at least one of the shaft, the retractormember, the anchor member, and the bit interact to exert a pressure thatprevents obstruction of the horse's airway.
 71. A method for treatmentof a breathing disorder in a horse, the method comprising: a) insertinga shaft through an epiglottis and a soft palate; b) connecting aretractor member at or near a first end of the shaft, the retractormember is external to the soft palate; and c) connecting an anchormember at or near a second end of the shaft, the anchor member isexternal to the epiglottis, wherein at least one of the shaft, theretractor member, and the anchor member interact to maintain theepiglottis adjacent to the soft palate and to prevent obstruction of thehorse's airway.
 72. The method of claim 71, the method furthercomprising: d) positioning a second retractor member in the region ofthe pharyngoglossal fold; e) connecting a first end of a second shaft ator near the second retractor member; and f) connecting a second end of ashaft at or near a second anchor member, attaching at least a portion ofthe second anchor member to the soft palate, wherein at least one of thesecond shaft, the second retractor member and the second anchor memberinteract to distribute a force and to prevent obstruction of the horse'sairway.
 73. A method for treatment of a breathing disorder, the methodcomprising: a) positioning a device on the floor of a patient's mouth;and b) applying a force to the device that displaces at least a portionof the floor of the patient's mouth and moves an adjacent soft tissue toprevent deformation of at least a portion of the patient's soft tissueso as to prevent obstruction of the patient's airway.
 74. The method ofclaim 73 wherein the soft tissue is the patient's tongue and the devicemoves at least a portion of the tongue in a direction away from thepatient's airway.
 75. The method of claim 73 wherein the devicecomprises a bolster and at least one of a shaft, a dental anchor, and apalatal prosthesis.
 76. A method for treatment of a breathing disorder,the method comprising: a) positioning a vacuum device on a segment of asoft tissue located in a patient's oral cavity or pharynx; and b)applying a vacuum to the vacuum device to displace at least a portion ofthe segment to alter the shape of the at least a portion of the segmentand to prevent deformation of at least a portion of the soft tissue soas to prevent obstruction of the patient's airway.
 77. The method ofclaim 76 wherein the vacuum device comprises one or more of a suctioncup, a tube, and a pump.
 78. The method of claim 76 wherein the softtissue is a tongue.
 79. The method of claim 76 further comprisingapplying a viscous material to the soft tissue prior to positioning thevacuum device.
 80. A tissue retractor for treatment of a breathingdisorder, the tissue retractor comprising: a) an anchor member sized forplacement on or in a patient's soft palate; b) a shaft having a firstend and a second end, the first end connected to the anchor member; andc) a retractor member connected at or near the second end of the shaft;and wherein at least one of the shaft and the retractor member ispositioned on or in a soft tissue located in the patient's oral cavityor pharynx, and the anchor member, the shaft, and the retractor memberexert a force that prevents deformation of at least a portion of thesoft tissue so as to prevent obstruction of the patient's airway. 81.The tissue retractor of claim 80 wherein the force is one of aretraction force or a protraction force.
 82. The tissue retractor ofclaim 80 wherein the soft tissue is the soft palate, the pharyngoglossalfold, the floor of mouth, or the tongue.
 83. The tissue retractor ofclaim 80 wherein the retractor member is a tongue stud on the surface ofa tongue.
 84. A method for treatment of a breathing disorder, the methodcomprising: a) positioning a palatal prosthesis on or in a patient'ssoft palate; b) positioning a retractor member on or in a soft tissuelocated in the patient's oral cavity or pharynx; c) connecting a firstend of a shaft to the palatal prosthesis; and d) connecting a second endof the shaft to the retractor member, wherein at least one of thepalatal prosthesis, the shaft, and the retractor member interact toexert a force that prevents deformation of at least a portion of thesoft tissue so as to prevent obstruction of the patient's airway. 85.The method of claim 84 wherein at least one of the palatal prosthesis,the shaft, and the retractor member interact to exert one of aretraction force or a protraction force that prevents deformation of atleast a portion of the soft tissue so as to prevent obstruction of thepatient's airway.
 86. A method for treatment of a breathing disorder,the method comprising: a) positioning a device on a soft tissue in apatient's mouth; b) applying a suction force to the device to suction atleast a portion of the soft tissue into the device; and c) retractingthe device to displace at least a portion of the soft tissue so as toprevent obstruction of the patient's airway.
 87. The method of claim 86wherein the soft tissue is the patient's tongue and the device moves atleast a portion of the tongue in a direction away from the patient'sairway.
 88. The method of claim 86 wherein a shaft comprising a lumenprovides the suction force and retracting the device comprises movingthe shaft in a direction away from the patient's airway.
 89. The methodof claim 86 wherein the device resists release of the at least a portionof the soft tissue when the suction force is released.